Method and apparatus for selecting operations of a surgical instrument based on user intention

ABSTRACT

Disclosed is a method for operating a surgical instrument, the surgical instrument comprising a radio frequency (RF) energy output, an ultrasonic energy output, and a first jaw and a second jaw configured for pivotal movement between a closed position and an open position, the method comprising: receiving a first input indicating a user selection of one of a first option and a second option; receiving a second input indicating whether the first jaw and the second jaw are in the closed position or in the open position; receiving a third input indicating electrical impedance at the RF energy output; and selecting a mode of operation for treating a tissue from a plurality of modes of operation based at least in part on the first input, the second input and the third input.

PRIORITY

This application claims the benefit of U.S. Provisional Application Ser.No. 62/235,260, titled GENERATOR FOR PROVIDING COMBINED RADIO FREQUENCYAND ULTRASONIC ENERGIES, filed Sep. 30, 2015, U.S. ProvisionalApplication Ser. No. 62/235,368, titled CIRCUIT TOPOLOGIES FORGENERATOR, filed Sep. 30, 2015, and U.S. Provisional Application Ser.No. 62/235,466, titled SURGICAL INSTRUMENT WITH USER ADAPTABLEALGORITHMS, filed Sep. 30, 2015, the contents of each of which areincorporated herein by reference in their entirety.

TECHNICAL FIELD

The present disclosure generally relates to ultrasonic surgical systems,electrosurgical systems, and combination electrosurgical/ultrasonicsystems for performing surgical procedures such as coagulating, sealing,and/or cutting tissue. In particular, the present disclosure relates tomethod and apparatus for selecting operations of a surgical instrumentbased on user intention.

BACKGROUND

Ultrasonic surgical instruments are finding increasingly widespreadapplications in surgical procedures by virtue of the unique performancecharacteristics of such instruments. Depending upon specific instrumentconfigurations and operational parameters, ultrasonic surgicalinstruments can provide substantially simultaneous cutting of tissue andhemostasis by coagulation, desirably minimizing patient trauma. Thecutting action is typically realized by an end effector, or blade tip,at the distal end of the instrument, which transmits ultrasonic energyto tissue brought into contact with the end effector. Ultrasonicinstruments of this nature can be configured for open surgical use,laparoscopic, or endoscopic surgical procedures includingrobotic-assisted procedures.

Some surgical instruments utilize ultrasonic energy for both precisecutting and controlled coagulation. Ultrasonic energy cuts andcoagulates by vibrating a blade in contact with tissue. Vibrating athigh frequencies (e.g., 55,500 times per second), the ultrasonic bladedenatures protein in the tissue to form a sticky coagulum. Pressureexerted on tissue with the blade surface collapses blood vessels andallows the coagulum to form a hemostatic seal. The precision of cuttingand coagulation is controlled by the surgeon's technique and adjustingthe power level, blade edge, tissue traction, and blade pressure.

Electrosurgical devices for applying electrical energy to tissue inorder to treat and/or destroy the tissue are also finding increasinglywidespread applications in surgical procedures. An electrosurgicaldevice typically includes a hand piece, an instrument having adistally-mounted end effector (e.g., one or more electrodes). The endeffector can be positioned against the tissue such that electricalcurrent is introduced into the tissue. Electrosurgical devices can beconfigured for bipolar or monopolar operation. During bipolar operation,current is introduced into and returned from the tissue by active andreturn electrodes, respectively, of the end effector. During monopolaroperation, current is introduced into the tissue by an active electrodeof the end effector and returned through a return electrode (e.g., agrounding pad) separately located on a patient's body. Heat generated bythe current flowing through the tissue may form hemostatic seals withinthe tissue and/or between tissues and thus may be particularly usefulfor sealing blood vessels, for example. The end effector of anelectrosurgical device may also include a cutting member that is movablerelative to the tissue and the electrodes to transect the tissue.

Electrical energy applied by an electrosurgical device can betransmitted to the instrument by a generator in communication with thehand piece. The electrical energy may be in the form of RF energy thatmay be in a frequency range described in EN 60601-2-2:2009+A11:2011,Definition 201.3.218—HIGH FREQUENCY. For example, the frequencies inmonopolar RF applications are typically restricted to less than 5 MHz.However, in bipolar RF applications, the frequency can be almostanything. Frequencies above 200 kHz can be typically used for MONOPOLARapplications in order to avoid the unwanted stimulation of nerves andmuscles which would result from the use of low frequency current. Lowerfrequencies may be used for BIPOLAR techniques if the RISK ANALYSISshows the possibility of neuromuscular stimulation has been mitigated toan acceptable level. Normally, frequencies above 5 MHz are not used inorder to minimize the problems associated with HIGH FREQUENCY LEAKAGECURRENTS. However, higher frequencies may be used in the case of BIPOLARtechniques. It is generally recognized that 10 mA is the lower thresholdof thermal effects on tissue.

In application, an electrosurgical device can transmit low frequency RFenergy through tissue, which causes ionic agitation, or friction, ineffect resistive heating, thereby increasing the temperature of thetissue. Because a sharp boundary is created between the affected tissueand the surrounding tissue, surgeons can operate with a high level ofprecision and control, without sacrificing un-targeted adjacent tissue.The low operating temperatures of RF energy is useful for removing,shrinking, or sculpting soft tissue while simultaneously sealing bloodvessels. RF energy works particularly well on connective tissue, whichis primarily comprised of collagen and shrinks when contacted by heat.

Other electrical surgical instruments include, without limitation,irreversible and/or reversible electroporation, and/or microwavetechnologies, among others. Accordingly, the techniques disclosed hereinare applicable to ultrasonic, bipolar or monopolar RF (electrosurgical),irreversible and/or reversible electroporation, and/or microwave basedsurgical instruments, among others.

SUMMARY

In one aspect, a method for operating a surgical instrument is provided,the surgical instrument comprising a radio frequency (RF) energy output,an ultrasonic energy output, and a first jaw and a second jaw configuredfor pivotal movement between a closed position and an open position, themethod comprising: receiving a first input indicating a user selectionof one of a first option and a second option; receiving a second inputindicating whether the first jaw and the second jaw are in the closedposition or in the open position; receiving a third input indicatingelectrical impedance at the RF energy output; and selecting a mode ofoperation for treating a tissue from a plurality of modes of operationbased at least in part on the first input, the second input and thethird input, wherein the plurality of modes of operation comprises: afirst mode wherein the RF energy output applies RF energy to the tissue;and a second mode wherein the ultrasonic energy output appliesultrasonic energy to the tissue.

In another aspect, a generator for delivering radio frequency (RF)energy and ultrasonic energy to a surgical instrument is provided, thesurgical instrument comprising a first jaw and a second jaw configuredfor pivotal movement between a closed position and an open position, thegenerator being configured to: receive a first input indicating a userselection of one of a first option and a second option; receive a secondinput indicating whether the first jaw and the second jaw are in theclosed position or in the open position; receive a third inputindicating electrical impedance at a RF energy output of the surgicalinstrument; and select a mode of operation for treating a tissue from aplurality of modes of operation based at least in part on the firstinput, the second input and the third input, wherein the plurality ofmodes of operation comprises: a first mode wherein the generatordelivers RF energy to the surgical instrument; and a second mode whereinthe generator delivers ultrasonic energy to the surgical instrument.

In yet another aspect, a surgical instrument is provided comprising: afirst jaw and a second jaw configured for pivotal movement between aclosed position and an open position; a radio frequency (RF) energyoutput configured to apply RF energy to a tissue at least when a firstmode of operation is selected; and an ultrasonic energy outputconfigured to apply ultrasonic energy to the tissue at least when asecond mode of operation is selected, wherein a mode of operation isselected from a plurality of modes of operation comprising the firstmode and the second mode based at least in part on a first input, asecond input and a third input, wherein: the first input indicates auser selection of one of a first option and a second option; the secondinput indicates whether the first jaw and the second jaw are in theclosed position or in the open position; and the third input indicateselectrical impedance at the RF energy output.

FIGURES

The novel features of the described forms are set forth withparticularity in the appended claims. The described forms, however, bothas to organization and methods of operation, may be best understood byreference to the following description, taken in conjunction with theaccompanying drawings in which:

FIG. 1 illustrates one form of a surgical system comprising a generatorand various surgical instruments usable therewith;

FIG. 2 is a diagram of the combination electrosurgical and ultrasonicinstrument shown in FIG. 1;

FIG. 3 is a diagram of the surgical system shown in FIG. 1;

FIG. 4 is a model illustrating motional branch current in one form;

FIG. 5 is a structural view of a generator architecture in one form;

FIG. 6 illustrates one form of a drive system of a generator, whichcreates the ultrasonic electrical signal for driving an ultrasonictransducer;

FIG. 7 illustrates one form of a drive system of a generator comprisinga tissue impedance module;

FIG. 8 illustrates an example of a combined radio frequency andultrasonic energy generator for delivering energy to a surgicalinstrument;

FIG. 9 is a diagram of a system for delivering combined radio frequencyand ultrasonic energy to a plurality of surgical instruments;

FIG. 10 illustrates a communications architecture of a system fordelivering combined radio frequency and ultrasonic energy to a pluralityof surgical instruments;

FIG. 11 illustrates a communications architecture of a system fordelivering combined radio frequency and ultrasonic energy to a pluralityof surgical instruments;

FIG. 12 illustrates a communications architecture of a system fordelivering combined radio frequency and ultrasonic energy to a pluralityof surgical instruments;

FIG. 13 shows a block diagram illustrating the selection of operationsof a surgical instrument based on various inputs;

FIG. 14 shows a logic diagram illustrating specific operations of asurgical instrument selected based on various inputs;

FIG. 15 provides an illustration of a system configuration for anexample circuit topology shown and described with regard to FIGS. 13-14,including metal-oxide semiconductor field effect transistor (MOSFET)switches and a control circuit in the handle, configured to manage RFand ultrasonic currents output by a generator according to one aspect ofthe present disclosure;

FIG. 16 provides an illustration of a system configuration for anexample circuit topology shown and described with regard to FIGS. 13-14,including bandstop filters and a control circuit in the handle,configured to manage RF and ultrasonic currents output by a generatoraccording to one aspect of the present disclosure;

FIG. 17 is an example graph of two waveforms of energy from a generator;

FIG. 18 is an example graph of the sum of the waveforms of FIG. 17;

FIG. 19 is an example graph of sum of the waveforms of FIG. 17 with theRF waveform dependent on the ultrasonic waveform;

FIG. 20 is an example graph of the sum of the waveforms of FIG. 17 withthe RF waveform being a function of the ultrasonic waveform; and

FIG. 21 is an example graph of a complex RF waveform with a high crestfactor.

DESCRIPTION

Before explaining various forms of ultrasonic surgical instruments indetail, it should be noted that the illustrative forms are not limitedin application or use to the details of construction and arrangement ofparts illustrated in the accompanying drawings and description. Theillustrative forms may be implemented or incorporated in other forms,variations and modifications, and may be practiced or carried out invarious ways. Further, unless otherwise indicated, the terms andexpressions employed herein have been chosen for the purpose ofdescribing the illustrative forms for the convenience of the reader andare not for the purpose of limitation thereof.

Further, it is understood that any one or more of thefollowing-described forms, expressions of forms, examples, can becombined with any one or more of the other following-described forms,expressions of forms, and examples.

Various forms are directed to improved ultrasonic surgical instrumentsconfigured for effecting tissue dissecting, cutting, and/or coagulationduring surgical procedures. In one form, an ultrasonic surgicalinstrument apparatus is configured for use in open surgical procedures,but has applications in other types of surgery, such as laparoscopic,endoscopic, and robotic-assisted procedures. Versatile use isfacilitated by selective use of ultrasonic energy.

This application is related to the following commonly owned patentapplications filed Sep. 7, 2016:

U.S. patent application Ser. No. 15/258,570, titled CIRCUIT TOPOLOGIESFOR COMBINED GENERATOR, by Wiener et al., now U.S. Patent ApplicationPublication No. 2017/0086908;

U.S. patent application Ser. No. 15/258,578, titled CIRCUITS FORSUPPLYING ISOLATED DIRECT CURRENT (DC) VOLTAGE TO SURGICAL INSTRUMENTS,by Wiener et al., now U.S. Patent Application Publication No.2017/0086911;

U.S. patent application Ser. No. 15/258,586, titled FREQUENCY AGILEGENERATOR FOR A SURGICAL INSTRUMENT, by Yates et al., now U.S. PatentApplication Publication No. 2017/0086909;

U.S. patent application Ser. No. 15/258,569, titled GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS FOR ELECTROSURGICAL ANDULTRASONIC SURGICAL INSTRUMENTS, by Wiener et al., now U.S. Pat. No.10,194,973;

U.S. patent application Ser. No. 15/258,611, titled GENERATOR FORDIGITALLY GENERATING COMBINED ELECTRICAL SIGNAL WAVEFORMS FOR ULTRASONICSURGICAL INSTRUMENTS, by Wiener et al., now U.S. Patent ApplicationPublication No. 2017/0086912;

U.S. patent application Ser. No. 15/258,650, titled PROTECTIONTECHNIQUES FOR GENERATOR FOR DIGITALLY GENERATING ELECTROSURGICAL ANDULTRASONIC DIGITAL ELECTRICAL SIGNAL WAVEFORMS, by Yates et al., nowU.S. Patent Application Publication No. 2017/0086913;

-   -   each of which is incorporated herein by reference in its        entirety.

This application also is related to the following commonly owned patentapplications filed on Jun. 9, 2016:

U.S. patent application Ser. No. 15/177,430, titled SURGICAL INSTRUMENTWITH USER ADAPTABLE TECHNIQUES;

U.S. patent application Ser. No. 15/177,439, titled SURGICAL INSTRUMENTWITH USER ADAPTABLE TECHNIQUES BASED ON TISSUE TYPE;

U.S. patent application Ser. No. 15/177,449, titled SURGICAL SYSTEM WITHUSER ADAPTABLE TECHNIQUES EMPLOYING MULTIPLE ENERGY MODALITIES BASED ONTISSUE;

U.S. patent application Ser. No. 15/177,456, titled SURGICAL SYSTEM WITHUSER ADAPTABLE TECHNIQUES BASED ON TISSUE IMPEDANCE;

U.S. patent application Ser. No. 15/177,466, titled SURGICAL SYSTEM WITHUSER ADAPTABLE TECHNIQUES EMPLOYING SIMULTANEOUS ENERGY MODALITIES BASEDON TISSUE PARAMETERS;

each of which is incorporated herein by reference in its entirety.

The various forms will be described in combination with an ultrasonicinstrument as described herein. Such description is provided by way ofexample, and not limitation, and is not intended to limit the scope andapplications thereof. For example, any one of the described forms isuseful in combination with a multitude of ultrasonic instrumentsincluding those described in, for example, U.S. Pat. Nos. 5,938,633;5,935,144; 5,944,737; 5,322,055; 5,630,420; and 5,449,370, which areeach incorporated by reference herein in their entirety.

As will become apparent from the following description, it iscontemplated that forms of the surgical instrument described herein maybe used in association with an oscillator unit of a surgical system,whereby ultrasonic energy from the oscillator unit provides the desiredultrasonic actuation for the present surgical instrument. It is alsocontemplated that forms of the surgical instrument described herein maybe used in association with a signal generator unit of a surgicalsystem, whereby electrical energy in the form of radio frequencies (RF),for example, is used to provide feedback to the user regarding thesurgical instrument. The ultrasonic oscillator and/or the signalgenerator unit may be non-detachably integrated with the surgicalinstrument or may be provided as separate components, which can beelectrically attachable to the surgical instrument.

One form of the present surgical apparatus is particularly configuredfor disposable use by virtue of its straightforward construction.However, it is also contemplated that other forms of the presentsurgical instrument can be configured for non-disposable or multipleuses. Detachable connection of the present surgical instrument with anassociated oscillator and signal generator unit is presently disclosedfor single-patient use for illustrative purposes only. However,non-detachable integrated connection of the present surgical instrumentwith an associated oscillator and/or signal generator unit is alsocontemplated. Accordingly, various forms of the presently describedsurgical instruments may be configured for single use and/or multipleuse with either detachable and/or non-detachable integral oscillatorand/or signal generator unit, without limitation, and all combinationsof such configurations are contemplated to be within the scope of thepresent disclosure.

In one aspect, the desired wave shape may be digitized by 1024 points,which are stored in a table, such as, for example, a DDS table (DirectDigital Synthesis table) with a FPGA (Field Programmable Gate Array) ofthe generator. The generator software and digital controls command theFPGA to scan the addresses in this table at the frequency of interestwhich in turn provides varying digital input values to a DAC that feedsto power amplifier. This method enables generating practically any (ormany) types of wave shapes fed into tissue. Furthermore, multiple waveshape tables can be created, stored and applied to tissue.

According to various aspects, a method comprises creating various typesof lookup tables in memory such as lookup tables generated by DirectDigital Synthesizers (DDS) and stored within Field Programmable GateArrays (FPGA), for example. Waveforms may be stored in the DDS table ortables as particular wave shapes. Examples of wave shapes in theRF/Electrosurgery tissue treatment field include high crest factor RFsignals, which may be used for surface coagulation in an RF mode, forexample, low crest factor RF signals, which may be used for deeperpenetration into tissue in an RF mode, for example, and waveforms thatpromote efficient touch-up coagulation, for example.

The present disclosure provides for the creation of multiple wave shapetables that allow for switching on the fly, either manually orautomatically, between the wave shapes based on tissue effect desired.Switching could be based on tissue parameters, such as, for example,tissue impedance and/or other factors. In addition to a traditional sinewave shape, in one aspect a generator may be configured to provide awave shape that maximizes the power into tissue per cycle. According toone aspect, the wave shape may be a trapezoid wave, a sine or cosinewave, a square wave, a triangle wave, or any combination thereof. In oneaspect, a generator may be configured to provide a wave shape or shapesthat are synchronized in such way that they make maximizing powerdelivery in the case that both RF and ultrasonic energy modalities aredriven, either simultaneously or sequentially. In one aspect, agenerator may be configured to provide a waveform that drives bothultrasonic and RF therapeutic energy simultaneously while maintainingultrasonic frequency lock. In one aspect, the generator may contain orbe associated with a device that provides a circuit topology thatenables simultaneously driving RF and ultrasonic energy. In one aspect,a generator may be configured to provide custom wave shapes that arespecific to a surgical instrument and the tissue effects provided bysuch a surgical instrument. Furthermore, the waveforms may be stored ina generator non-volatile memory or in an instrument memory, such as, forexample, an EEPROM. The waveform or waveforms may be fetched uponinstrument connection to a generator.

With reference to FIGS. 1-5, one form of a surgical system 10 includingan ultrasonic surgical instrument is illustrated. FIG. 1 illustrates oneform of a surgical system 10 comprising a generator 100 and varioussurgical instruments 104, 106, 108 usable therewith. FIG. 2 is a diagramof the ultrasonic surgical instrument 108 shown in FIG. 1. Withreference to both FIGS. 1 and 2, the generator 100 is configurable foruse with a variety of surgical instruments.

According to various forms, the generator 100 may be configurable foruse with different surgical instruments of different types including,for example, the ultrasonic device 104, electrosurgical or RF surgicalinstruments, such as, the RF device 106, and multifunction devices 108that integrate electrosurgical RF and ultrasonic energies deliveredsimultaneously from the generator 100. Although in the form of FIG. 1,the generator 100 is shown separate from the surgical instruments 104,106, 108 in one form, the generator 100 may be formed integrally witheither of the surgical instruments 104, 106, 108 to form a unitarysurgical system. The generator 100 comprises an input device 112 locatedon a front panel of the generator 100 console. The input device 112 maycomprise any suitable device that generates signals suitable forprogramming the operation of the generator 100.

FIG. 1 illustrates a generator 100 configured to drive multiple surgicalinstruments 104, 106, 108. The first surgical instrument 104 comprises ahandpiece 105, an ultrasonic transducer 120, a shaft 126, and an endeffector 122. The end effector 122 comprises an ultrasonic blade 128acoustically coupled to the transducer 120 and a clamp arm 140. Thehandpiece 105 comprises a trigger 143 to operate the clamp arm 140 and acombination of the toggle buttons 134 a, 134 b, 134 c to energize anddrive the ultrasonic blade 128 or other function. The toggle buttons 134a, 134 b, 134 c can be configured to energize the ultrasonic transducer120 with the generator 100.

Still with reference to FIG. 1, the generator 100 also is configured todrive a second surgical instrument 106. The second surgical instrument106 is an RF electrosurgical instrument and comprises a handpiece 107, ashaft 127, and an end effector 124. The end effector 124 compriseselectrodes in the clamp 142 a and return through the ultrasonic blade142 b. The electrodes are coupled to and energized by a bipolar energysource within the generator 100. The handpiece 107 comprises a trigger145 to operate the clamp arm 142 a and an energy button 135 to actuatean energy switch to energize the electrodes in the end effector 124.

Still with reference to FIG. 1, the generator 100 also is configures todrive a combination electrosurgical and ultrasonic instrument 108. Thecombination electrosurgical and ultrasonic multifunction surgicalinstrument 108 comprises a handpiece 109, a shaft 129, and an endeffector 125. The end effector 125 comprises an ultrasonic blade 149 anda clamp arm 146. The ultrasonic blade 149 is acoustically coupled to theultrasonic transducer 120. The handpiece 109 comprises a trigger 147 tooperate the clamp arm 146 and a combination of the toggle buttons 137 a,137 b, 137 c to energize and drive the ultrasonic blade 149 or otherfunction. The toggle buttons 137 a, 137 b, 137 c can be configured toenergize the ultrasonic transducer 120 with the generator 100 andenergize the ultrasonic blade 149 with a bipolar energy source alsocontained within the generator 100.

With reference to both FIGS. 1 and 2, the generator 100 is configurablefor use with a variety of surgical instruments. According to variousforms, the generator 100 may be configurable for use with differentsurgical instruments of different types including, for example, theultrasonic surgical instrument 104, the electrosurgical or RF surgicalinstruments, such as, the RF electrosurgical instrument 106, and themultifunction surgical instrument 108 that integrate electrosurgical RFand ultrasonic energies delivered simultaneously from the generator 100.Although in the form of FIG. 1, the generator 100 is shown separate fromthe surgical instruments 104, 106, 108, in one form, the generator 100may be formed integrally with either of the surgical instrument 104,106, 108 to form a unitary surgical system. The generator 100 comprisesan input device 110 located on a front panel of the generator 100console. The input device 110 may comprise any suitable device thatgenerates signals suitable for programming the operation of thegenerator 100. The generator 100 also may comprise one or more outputdevices 112.

With reference now to FIG. 2, the generator 100 is coupled to thecombination electrosurgical and ultrasonic multifunction surgicalinstrument 108. The generator 100 is coupled to the ultrasonictransducer 120 via a cable 144. The ultrasonic transducer 120 and awaveguide extending through a shaft 129 (waveguide not shown in FIG. 2)may collectively form an ultrasonic drive system driving an ultrasonicblade 149 of an end effector 125. The end effector 125 further maycomprise a clamp arm 146 to clamp tissue located between the clamp arm146 and the ultrasonic blade 149. In one form, the generator 100 may beconfigured to produce a drive signal of a particular voltage, current,and/or frequency output signal that can be stepped or otherwise modifiedwith high resolution, accuracy, and repeatability.

Still with reference to FIG. 2, It will be appreciated that the surgicalinstrument 108 may comprise any combination of the toggle buttons 137 a,137 b, 134 c. For example, the surgical instrument 104 could beconfigured to have only two toggle buttons: a toggle button 134 a forproducing maximum ultrasonic energy output and a toggle button 134 c forproducing a pulsed output at either the maximum or less than maximumpower level. In this way, the drive signal output configuration of thegenerator 100 could be 5 continuous signals and 5 or 4 or 3 or 2 or 1pulsed signals. In certain forms, the specific drive signalconfiguration may be controlled based upon, for example, EEPROM settingsin the generator 100 and/or user power level selection(s).

In certain forms, a two-position switch may be provided as analternative to a toggle button 134 c. For example, a surgical instrument104 may include a toggle button 134 a for producing a continuous outputat a maximum power level and a two-position toggle button 134 b. In afirst detented position, toggle button 134 b may produce a continuousoutput at a less than maximum power level, and in a second detentedposition the toggle button 134 b may produce a pulsed output (e.g., ateither a maximum or less than maximum power level, depending upon theEEPROM settings).

Still with reference to FIG. 2, forms of the generator 100 may enablecommunication with instrument-based data circuits. For example, thegenerator 100 may be configured to communicate with a first data circuit136 and/or a second data circuit 138. For example, the first datacircuit 136 may indicate a burn-in frequency slope, as described herein.Additionally or alternatively, any type of information may becommunicated to second data circuit for storage therein via a datacircuit interface (e.g., using a logic device). Such information maycomprise, for example, an updated number of operations in which theinstrument has been used and/or dates and/or times of its usage. Incertain forms, the second data circuit may transmit data acquired by oneor more sensors (e.g., an instrument-based temperature sensor). Incertain forms, the second data circuit may receive data from thegenerator 100 and provide an indication to a user (e.g., an LEDindication or other visible indication) based on the received data. Thesecond data circuit 138 contained in the multifunction surgicalinstrument 108 of a surgical instrument. In some forms, the second datacircuit 138 may be implemented in a many similar to that of the firstdata circuit 136 described herein. An instrument interface circuit maycomprise a second data circuit interface to enable this communication.In one form, the second data circuit interface may comprise a tri-statedigital interface, although other interfaces also may be used. Incertain forms, the second data circuit may generally be any circuit fortransmitting and/or receiving data. In one form, for example, the seconddata circuit may store information pertaining to the particular surgicalinstrument with which it is associated. Such information may include,for example, a model number, a serial number, a number of operations inwhich the surgical instrument has been used, and/or any other type ofinformation. In some forms, the second data circuit 138 may storeinformation about the electrical and/or ultrasonic properties of anassociated transducer 120, end effector 122, or ultrasonic drive system.Various processes and techniques described herein may be executed by agenerator. It will be appreciated, however, that in certain exampleforms, all or a part of these processes and techniques may be performedby internal logic 139 of the multifunction surgical instrument 108.

FIG. 3 is a diagram of the surgical system 10 of FIG. 1. In variousforms, the generator 100 may comprise several separate functionalelements, such as modules and/or blocks. Different functional elementsor modules may be configured for driving the different kinds of surgicalinstruments 104, 106, 108. For example, an ultrasonic generator module114 may drive ultrasonic devices such as the ultrasonic device 104 via acable 141. An electrosurgery/RF generator module 116 may drive theelectrosurgical device 106 via a cable 143. The respective modules 114,116, 118 may be combined as a combined RF generator/ultrasonic generatormodule 116 to generate both respective drive signals for driving thecombination RF electrosurgical/ultrasonic surgical instruments 108 via acable 144. In various forms, the ultrasonic generator module 114 and/orthe electrosurgery/RF generator module 118 each may be formed integrallywith the generator 100. Alternatively, one or more of the modules 114,116, 118 may be provided as a separate circuit module electricallycoupled to the generator 100. (The modules 114, 116, 118 are shown inphantom to illustrate this option.) Also, in some forms, theelectrosurgery/RF generator module 116 may be formed integrally with theultrasonic generator module 114, or vice versa. Also, in some forms, thegenerator 100 may be omitted entirely and the modules 114, 116, 118 maybe executed by processors or other hardware within the respectiveinstruments 104, 106, 108.

In other forms, the electrical outputs of the ultrasonic generatormodule 114 and the electrosurgery/RF generator module 116 may becombined into a single electrical signal capable of driving themultifunction device 108 simultaneously with electrosurgical RF andultrasonic energies. The multifunction device 108 comprises anultrasonic transducer 120 coupled to an ultrasonic blade and one or moreelectrodes in the end effector 122, 124 to receive electrosurgical RFenergy. In such implementations, the combined RF/ultrasonic signal iscoupled to the multifunction device 108. The multifunction device 108comprises signal processing components to split the combinedRF/ultrasonic signal such that the RF signal can be delivered to theelectrodes in the end effector 122 and the ultrasonic signal can bedelivered to the ultrasonic transducer 120.

In accordance with the described forms, the ultrasonic generator module114 may produce a drive signal or signals of particular voltages,currents, and frequencies, e.g., 55,500 cycles per second (Hz). Thedrive signal or signals may be provided to the ultrasonic device 104,and specifically to the transducer 120, which may operate, for example,as described above. The transducer 120 and a waveguide extending throughthe shaft 129 (waveguide not shown in FIG. 2) may collectively form anultrasonic drive system driving an ultrasonic blade 128 of an endeffector 125. In one form, the generator 100 may be configured toproduce a drive signal of a particular voltage, current, and/orfrequency output signal that can be stepped or otherwise modified withhigh resolution, accuracy, and repeatability.

The generator 100 may be activated to provide the drive signal to thetransducer 120 in any suitable manner. For example, the generator 100may comprise a foot switch 130 coupled to the generator 100 via afootswitch cable 132. A clinician may activate the transducer 120 bydepressing the foot switch 130. In addition, or instead of the footswitch 130 some forms of the ultrasonic device 104 may utilize one ormore switches positioned on the hand piece that, when activated, maycause the generator 100 to activate the transducer 120. In one form, forexample, the one or more switches may comprise a pair of toggle buttons137 a, 137 b (FIG. 2), for example, to determine an operating mode ofthe device 104. When the toggle button 137 a is depressed, for example,the ultrasonic generator 100 may provide a maximum drive signal to thetransducer 120, causing it to produce maximum ultrasonic energy output.Depressing toggle button 137 b may cause the ultrasonic generator 100 toprovide a user-selectable drive signal to the transducer 120, causing itto produce less than the maximum ultrasonic energy output. The device108 additionally or alternatively may comprise a second switch (notshown) to, for example, indicate a position of a jaw closure trigger foroperating jaws of the end effector 125. Also, in some forms, theultrasonic generator 100 may be activated based on the position of thejaw closure trigger, (e.g., as the clinician depresses the jaw closuretrigger to close the jaws, ultrasonic energy may be applied).

Additionally or alternatively, the one or more switches may comprise atoggle button 137 c that, when depressed, causes the generator 100 toprovide a pulsed output. The pulses may be provided at any suitablefrequency and grouping, for example. In certain forms, the power levelof the pulses may be the power levels associated with toggle buttons 137a, 137 b (maximum, less than maximum), for example.

It will be appreciated that a device 108 may comprise any combination ofthe toggle buttons 137 a, 137 b, 137 c. For example, the device 108could be configured to have only two toggle buttons: a toggle button 137a for producing maximum ultrasonic energy output and a toggle button 137c for producing a pulsed output at either the maximum or less thanmaximum power level. In this way, the drive signal output configurationof the generator 100 could be 5 continuous signals and 5 or 4 or 3 or 2or 1 pulsed signals. In certain forms, the specific drive signalconfiguration may be controlled based upon, for example, EEPROM settingsin the generator 100 and/or user power level selection(s).

In certain forms, a two-position switch may be provided as analternative to a toggle button 137 c. For example, a device 104 mayinclude a toggle button 137 a for producing a continuous output at amaximum power level and a two-position toggle button 137 b. In a firstdetented position, toggle button 137 b may produce a continuous outputat a less than maximum power level, and in a second detented positionthe toggle button 137 b may produce a pulsed output (e.g., at either amaximum or less than maximum power level, depending upon the EEPROMsettings).

In accordance with the described forms, the electrosurgery/RF generatormodule 116 may generate a drive signal or signals with output powersufficient to perform bipolar electrosurgery using radio frequency (RF)energy. In bipolar electrosurgery applications, the drive signal may beprovided, for example, to electrodes of the electrosurgical device 106,for example. Accordingly, the generator 100 may be configured fortherapeutic purposes by applying electrical energy to the tissuesufficient for treating the tissue (e.g., coagulation, cauterization,tissue welding).

The generator 100 may comprise an input device 112 (FIG. 1) located, forexample, on a front panel of the generator 100 console. The input device112 may comprise any suitable device that generates signals suitable forprogramming the operation of the generator 100. In operation, the usercan program or otherwise control operation of the generator 100 usingthe input device 112. The input device 112 may comprise any suitabledevice that generates signals that can be used by the generator (e.g.,by one or more processors contained in the generator) to control theoperation of the generator 100 (e.g., operation of the ultrasonicgenerator module 114, electrosurgery/RF generator module 116, combinedRF generator/ultrasonic generator 118). In various forms, the inputdevice 112 includes one or more of buttons, switches, thumbwheels,keyboard, keypad, touch screen monitor, pointing device, remoteconnection to a general purpose or dedicated computer. In other forms,the input device 112 may comprise a suitable user interface, such as oneor more user interface screens displayed on a touch screen monitor, forexample. Accordingly, by way of the input device 112, the user can setor program various operating parameters of the generator, such as, forexample, current ( ), voltage (V), frequency (f), and/or period (T) of adrive signal or signals generated by the ultrasonic generator module 114and/or electrosurgery/RF generator module 116.

The generator 100 may also comprise an output device 110 (FIG. 1), suchas an output indicator, located, for example, on a front panel of thegenerator 100 console. The output device 110 includes one or moredevices for providing a sensory feedback to a user. Such devices maycomprise, for example, visual feedback devices (e.g., a visual feedbackdevice may comprise incandescent lamps, light emitting diodes (LEDs),graphical user interface, display, analog indicator, digital indicator,bar graph display, digital alphanumeric display, LCD display screen, LEDindicators), audio feedback devices (e.g., an audio feedback device maycomprise speaker, buzzer, audible, computer generated tone, computerizedspeech, voice user interface (VUI) to interact with computers through avoice/speech platform), or tactile feedback devices (e.g., a tactilefeedback device comprises any type of vibratory feedback, hapticactuator).

Although certain modules and/or blocks of the generator 100 may bedescribed by way of example, it can be appreciated that a greater orlesser number of modules and/or blocks may be used and still fall withinthe scope of the forms. Further, although various forms may be describedin terms of modules and/or blocks to facilitate description, suchmodules and/or blocks may be implemented by one or more hardwarecomponents, e.g., processors, Digital Signal Processors (DSPs),Programmable Logic Devices (PLDs), Application Specific IntegratedCircuits (ASICs), circuits, registers and/or software components, e.g.,programs, subroutines, logic and/or combinations of hardware andsoftware components. Also, in some forms, the various modules describedherein may be implemented utilizing similar hardware positioned withinthe instruments 104, 106, 108 (i.e., the external generator 100 may beomitted).

In one form, the ultrasonic generator drive module 114 andelectrosurgery/RF drive module 116 may comprise one or more embeddedapplications implemented as firmware, software, hardware, or anycombination thereof. The modules 114, 116, 118 may comprise variousexecutable modules such as software, programs, data, drivers,application program interfaces (APIs), and so forth. The firmware may bestored in nonvolatile memory (NVM), such as in bit masked read-onlymemory (ROM) or flash memory. In various implementations, storing thefirmware in ROM may preserve flash memory. The NVM may comprise othertypes of memory including, for example, programmable ROM (PROM),erasable programmable ROM (EPROM), electrically erasable programmableROM (EEPROM), or battery backed random-access memory (RAM) such asdynamic RAM (DRAM), Double-Data-Rate DRAM (DDRAM), and/or synchronousDRAM (SDRAM).

In one form, the modules 114, 116, 118 comprise a hardware componentimplemented as a processor for executing program instructions formonitoring various measurable characteristics of the devices 104, 106,108 and generating a corresponding output control signals for operatingthe devices 104, 106, 108. In forms in which the generator 100 is usedin conjunction with the device 108, the output control signal may drivethe ultrasonic transducer 120 in cutting and/or coagulation operatingmodes. Electrical characteristics of the device 108 and/or tissue may bemeasured and used to control operational aspects of the generator 100and/or provided as feedback to the user. In forms in which the generator100 is used in conjunction with the device 108, the output controlsignal may supply electrical energy (e.g., RF energy) to the endeffector 125 in cutting, coagulation and/or desiccation modes.Electrical characteristics of the device 108 and/or tissue may bemeasured and used to control operational aspects of the generator 100and/or provide feedback to the user. In various forms, as previouslydiscussed, the hardware component may be implemented as a DSP, PLD,ASIC, circuits, and/or registers. In one form, the processor may beconfigured to store and execute computer software program instructionsto generate the step function output signals for driving variouscomponents of the devices 104, 106, 108, such as the ultrasonictransducer 120 and the end effectors 122, 124, 125.

FIG. 4 illustrates an equivalent circuit 150 of an ultrasonictransducer, such as the ultrasonic transducer 120, according to oneform. The circuit 150 comprises a first “motional” branch having aserially connected inductance L_(s), resistance R_(s) and capacitanceC_(s) that define the electromechanical properties of the resonator, anda second capacitive branch having a static capacitance C_(o). Drivecurrent I_(G) may be received from a generator at a drive voltage V_(g),with motional current I_(m) flowing through the first branch and currentI_(g)-I_(m) flowing through the capacitive branch. Control of theelectromechanical properties of the ultrasonic transducer may beachieved by suitably controlling I_(g) and V_(g). As explained above,conventional generator architectures may include a tuning inductor L_(t)(shown in phantom in FIG. 4) for tuning out in a parallel resonancecircuit the static capacitance C_(o) at a resonant frequency so thatsubstantially all of generator's current output I_(g) flows through themotional branch. In this way, control of the motional branch currentI_(m) is achieved by controlling the generator current output I_(g). Thetuning inductor L_(t) is specific to the static capacitance C_(o) of anultrasonic transducer, however, and a different ultrasonic transducerhaving a different static capacitance requires a different tuninginductor L_(t). Moreover, because the tuning inductor L_(t) is matchedto the nominal value of the static capacitance C_(o) at a singleresonant frequency, accurate control of the motional branch currentI_(m) is assured only at that frequency, and as frequency shifts downwith transducer temperature, accurate control of the motional branchcurrent is compromised.

Forms of the generator 100 do not rely on a tuning inductor L_(t) tomonitor the motional branch current I_(m). Instead, the generator 100may use the measured value of the static capacitance C_(o) in betweenapplications of power for a specific ultrasonic surgical instrument 104(along with drive signal voltage and current feedback data) to determinevalues of the motional branch current I_(m) on a dynamic and ongoingbasis (e.g., in real-time). Such forms of the generator 100 aretherefore able to provide virtual tuning to simulate a system that istuned or resonant with any value of static capacitance C_(o) at anyfrequency, and not just at single resonant frequency dictated by anominal value of the static capacitance C_(o).

FIG. 5 is a simplified block diagram of a generator 200, which is oneform of the generator 100 (FIGS. 1-3). The generator is configured toprovide inductorless tuning as described above, among other benefits.Additional details of the generator 200 are described in commonlyassigned and contemporaneously filed U.S. Pat. No. 9,060,775, titledSURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, thedisclosure of which is incorporated herein by reference in its entirety.With reference to FIG. 5, the generator 200 may comprise a patientisolated stage 202 in communication with a non-isolated stage 204 via apower transformer 206. A secondary winding 208 of the power transformer206 is contained in the isolated stage 202 and may comprise a tappedconfiguration (e.g., a center-tapped or a non-center-tappedconfiguration) to define drive signal outputs 210 a, 210 b, 210 c foroutputting drive signals to different surgical instruments, such as, forexample, an ultrasonic surgical instrument 104, electrosurgical device106, and combination electrosurgical/ultrasonic device 108. Inparticular, drive signal outputs 210 a, 210 c may output an ultrasonicdrive signal (e.g., a 420 V RMS drive signal) to an ultrasonic surgicalinstrument 104, and drive signal outputs 210 b, 210 c may output anelectrosurgical drive signal (e.g., a 100 V RMS drive signal) to anelectrosurgical device 106, with output 210 b corresponding to thecenter tap of the power transformer 206.

In certain forms, the ultrasonic and electrosurgical drive signals maybe provided simultaneously to distinct surgical instruments and/or to asingle surgical instrument having the capability to deliver bothultrasonic and electrosurgical energy to tissue, such as multifunctiondevice 108 (FIGS. 1-3). It will be appreciated that the electrosurgicalsignal, provided either to a dedicated electrosurgical instrument and/orto a combined multifunction ultrasonic/electrosurgical instrument may beeither a therapeutic or sub-therapeutic level signal. For example, theultrasonic and radio frequency signals can be delivered separately orsimultaneously from a generator with a single output port in order toprovide the desired output signal to the surgical instrument, as will bediscussed in more detail below. Accordingly, the generator can combinethe ultrasonic and electrosurgical RF energies and deliver the combinedenergies to the multifunction ultrasonic/electrosurgical instrument.Bipolar electrodes can be placed on one or both jaws of the endeffector. One jaw may be driven by ultrasonic energy in addition toelectrosurgical RF energy, working simultaneously. The ultrasonic energymay be employed to dissect tissue while the electrosurgical RF energymay be employed for vessel sealing.

The non-isolated stage 204 may comprise a power amplifier 212 having anoutput connected to a primary winding 214 of the power transformer 206.In certain forms the power amplifier 206 may be comprise a push-pullamplifier. For example, the non-isolated stage 204 may further comprisea logic device 216 for supplying a digital output to a digital-to-analogconverter (DAC) 218, which in turn supplies a corresponding analogsignal to an input of the power amplifier 212. In certain forms thelogic device 216 may comprise a programmable gate array (PGA), afield-programmable gate array (FPGA), programmable logic device (PLD),among other logic circuits, for example. The logic device 216, by virtueof controlling the input of the power amplifier 212 via the DAC 218, maytherefore control any of a number of parameters (e.g., frequency,waveform shape, waveform amplitude) of drive signals appearing at thedrive signal outputs 210 a, 210 b, 210 c. In certain forms and asdiscussed below, the logic device 216, in conjunction with a processor(e.g., a digital signal processor discussed below), may implement anumber of digital signal processing (DSP)-based and/or other controlalgorithms to control parameters of the drive signals output by thegenerator 200.

Power may be supplied to a power rail of the power amplifier 212 by aswitch-mode regulator 220. In certain forms the switch-mode regulator220 may comprise an adjustable buck regulator, for example. Thenon-isolated stage 204 may further comprise a first processor 222, whichin one form may comprise a DSP processor such as an Analog DevicesADSP-21469 SHARC DSP, available from Analog Devices, Norwood, Mass., forexample, although in various forms any suitable processor may beemployed. In certain forms the processor 222 may control operation ofthe switch-mode power converter 220 responsive to voltage feedback datareceived from the power amplifier 212 by the DSP processor 222 via ananalog-to-digital converter (ADC) 224. In one form, for example, the DSPprocessor 222 may receive as input, via the ADC 224, the waveformenvelope of a signal (e.g., an RF signal) being amplified by the poweramplifier 212. The DSP processor 222 may then control the switch-moderegulator 220 (e.g., via a pulse-width modulated (PWM) output) such thatthe rail voltage supplied to the power amplifier 212 tracks the waveformenvelope of the amplified signal. By dynamically modulating the railvoltage of the power amplifier 212 based on the waveform envelope, theefficiency of the power amplifier 212 may be significantly improvedrelative to a fixed rail voltage amplifier schemes.

In certain forms, the logic device 216, in conjunction with the DSPprocessor 222, may implement a digital synthesis circuit such as adirect digital synthesizer (DDS) (see e.g., FIGS. 13, 14) control schemeto control the waveform shape, frequency and/or amplitude of drivesignals output by the generator 200. In one form, for example, the logicdevice 216 may implement a DDS control algorithm by recalling waveformsamples stored in a dynamically-updated lookup table (LUT), such as aRAM LUT, which may be embedded in an FPGA. This control algorithm isparticularly useful for ultrasonic applications in which an ultrasonictransducer, such as the ultrasonic transducer 120, may be driven by aclean sinusoidal current at its resonant frequency. Because otherfrequencies may excite parasitic resonances, minimizing or reducing thetotal distortion of the motional branch current may correspondinglyminimize or reduce undesirable resonance effects. Because the waveformshape of a drive signal output by the generator 200 is impacted byvarious sources of distortion present in the output drive circuit (e.g.,the power transformer 206, the power amplifier 212), voltage and currentfeedback data based on the drive signal may be input into an algorithm,such as an error control algorithm implemented by the DSP processor 222,which compensates for distortion by suitably pre-distorting or modifyingthe waveform samples stored in the LUT on a dynamic, ongoing basis(e.g., in real-time). In one form, the amount or degree ofpre-distortion applied to the LUT samples may be based on the errorbetween a computed motional branch current and a desired currentwaveform shape, with the error being determined on a sample-by-samplebasis. In this way, the pre-distorted LUT samples, when processedthrough the drive circuit, may result in a motional branch drive signalhaving the desired waveform shape (e.g., sinusoidal) for optimallydriving the ultrasonic transducer. In such forms, the LUT waveformsamples will therefore not represent the desired waveform shape of thedrive signal, but rather the waveform shape that is required toultimately produce the desired waveform shape of the motional branchdrive signal when distortion effects are taken into account.

The non-isolated stage 204 may further comprise an ADC 226 and an ADC228 coupled to the output of the power transformer 206 via respectiveisolation transformers 230, 232 for respectively sampling the voltageand current of drive signals output by the generator 200. In certainforms, the ADCs 226, 228 may be configured to sample at high speeds(e.g., 80 MSPS) to enable oversampling of the drive signals. In oneform, for example, the sampling speed of the ADCs 226, 228 may enableapproximately 200× (depending on frequency) oversampling of the drivesignals. In certain forms, the sampling operations of the ADC 226, 228may be performed by a singe ADC receiving input voltage and currentsignals via a two-way multiplexer. The use of high-speed sampling informs of the generator 200 may enable, among other things, calculationof the complex current flowing through the motional branch (which may beused in certain forms to implement DDS-based waveform shape controldescribed above), accurate digital filtering of the sampled signals, andcalculation of real power consumption with a high degree of precision.Voltage and current feedback data output by the ADCs 226, 228 may bereceived and processed (e.g., FIFO buffering, multiplexing) by the logicdevice 216 and stored in data memory for subsequent retrieval by, forexample, the DSP processor 222. As noted above, voltage and currentfeedback data may be used as input to an algorithm for pre-distorting ormodifying LUT waveform samples on a dynamic and ongoing basis. Incertain forms, this may require each stored voltage and current feedbackdata pair to be indexed based on, or otherwise associated with, acorresponding LUT sample that was output by the logic device 222 whenthe voltage and current feedback data pair was acquired. Synchronizationof the LUT samples and the voltage and current feedback data in thismanner contributes to the correct timing and stability of thepre-distortion algorithm.

In certain forms, the voltage and current feedback data may be used tocontrol the frequency and/or amplitude (e.g., current amplitude) of thedrive signals. In one form, for example, voltage and current feedbackdata may be used to determine impedance phase. The frequency of thedrive signal may then be controlled to minimize or reduce the differencebetween the determined impedance phase and an impedance phase setpoint(e.g., 0°), thereby minimizing or reducing the effects of harmonicdistortion and correspondingly enhancing impedance phase measurementaccuracy. The determination of phase impedance and a frequency controlsignal may be implemented in the DSP processor 222, for example, withthe frequency control signal being supplied as input to a DDS controlalgorithm implemented by the logic device 216.

In another form, for example, the current feedback data may be monitoredin order to maintain the current amplitude of the drive signal at acurrent amplitude setpoint. The current amplitude setpoint may bespecified directly or determined indirectly based on specified voltageamplitude and power setpoints. In certain forms, control of the currentamplitude may be implemented by control algorithm, such as, for example,a PID control algorithm, in the processor 222. Variables controlled bythe control algorithm to suitably control the current amplitude of thedrive signal may include, for example, the scaling of the LUT waveformsamples stored in the logic device 216 and/or the full-scale outputvoltage of the DAC 218 (which supplies the input to the power amplifier212) via a DAC 234.

The non-isolated stage 204 may further comprise a second processor 236for providing, among other things user interface (UI) functionality. Inone form, the UI processor 236 may comprise an Atmel AT91SAM9263processor having an ARM 926EJ-S core, available from Atmel Corporation,San Jose, Calif., for example. Examples of UI functionality supported bythe UI processor 236 may include audible and visual user feedback,communication with peripheral devices (e.g., via a Universal Serial Bus(USB) interface), communication with the footswitch 130, communicationwith an input device 112 (e.g., a touch screen display) andcommunication with an output device 110 (e.g., a speaker). The UIprocessor 236 may communicate with the processor 222 and the logicdevice 216 (e.g., via serial peripheral interface (SPI) buses). Althoughthe UI processor 236 may primarily support UI functionality, it may alsocoordinate with the DSP processor 222 to implement hazard mitigation incertain forms. For example, the UI processor 236 may be programmed tomonitor various aspects of user input and/or other inputs (e.g., touchscreen inputs, footswitch 130 inputs (FIG. 3), temperature sensorinputs) and may disable the drive output of the generator 200 when anerroneous condition is detected.

In certain forms, both the DSP processor 222 and the UI processor 236,for example, may determine and monitor the operating state of thegenerator 200. For the DSP processor 222, the operating state of thegenerator 200 may dictate, for example, which control and/or diagnosticprocesses are implemented by the DSP processor 222. For the UI processor236, the operating state of the generator 200 may dictate, for example,which elements of a user interface (e.g., display screens, sounds) arepresented to a user. The respective DSP and UI processors 222, 236 mayindependently maintain the current operating state of the generator 200and recognize and evaluate possible transitions out of the currentoperating state. The DSP processor 222 may function as the master inthis relationship and determine when transitions between operatingstates are to occur. The UI processor 236 may be aware of validtransitions between operating states and may confirm if a particulartransition is appropriate. For example, when the DSP processor 222instructs the UI processor 236 to transition to a specific state, the UIprocessor 236 may verify that requested transition is valid. In theevent that a requested transition between states is determined to beinvalid by the UI processor 236, the UI processor 236 may cause thegenerator 200 to enter a failure mode.

The non-isolated stage 204 may further comprise a controller 238 formonitoring input devices 112 (e.g., a capacitive touch sensor used forturning the generator 200 on and off, a capacitive touch screen). Incertain forms, the controller 238 may comprise at least one processorand/or other controller device in communication with the UI processor236. In one form, for example, the controller 238 may comprise aprocessor (e.g., a Mega168 8-bit controller available from Atmel)configured to monitor user input provided via one or more capacitivetouch sensors. In one form, the controller 238 may comprise a touchscreen controller (e.g., a QT5480 touch screen controller available fromAtmel) to control and manage the acquisition of touch data from acapacitive touch screen.

In certain forms, when the generator 200 is in a “power off” state, thecontroller 238 may continue to receive operating power (e.g., via a linefrom a power supply of the generator 200, such as the power supply 254discussed below). In this way, the controller 238 may continue tomonitor an input device 112 (e.g., a capacitive touch sensor located ona front panel of the generator 200) for turning the generator 200 on andoff. When the generator 200 is in the power off state, the controller238 may wake the power supply (e.g., enable operation of one or moreDC/DC voltage converters 256 of the power supply 254) if activation ofthe “on/off” input device 112 by a user is detected. The controller 238may therefore initiate a sequence for transitioning the generator 200 toa “power on” state. Conversely, the controller 238 may initiate asequence for transitioning the generator 200 to the power off state ifactivation of the “on/off” input device 112 is detected when thegenerator 200 is in the power on state. In certain forms, for example,the controller 238 may report activation of the “on/off” input device112 to the processor 236, which in turn implements the necessary processsequence for transitioning the generator 200 to the power off state. Insuch forms, the controller 238 may have no independent ability forcausing the removal of power from the generator 200 after its power onstate has been established.

In certain forms, the controller 238 may cause the generator 200 toprovide audible or other sensory feedback for alerting the user that apower on or power off sequence has been initiated. Such an alert may beprovided at the beginning of a power on or power off sequence and priorto the commencement of other processes associated with the sequence.

In certain forms, the isolated stage 202 may comprise an instrumentinterface circuit 240 to, for example, provide a communication interfacebetween a control circuit of a surgical instrument (e.g., a controlcircuit comprising hand piece switches) and components of thenon-isolated stage 204, such as, for example, the programmable logicdevice 216, the DSP processor 222 and/or the UI processor 236. Theinstrument interface circuit 240 may exchange information withcomponents of the non-isolated stage 204 via a communication link thatmaintains a suitable degree of electrical isolation between the stages202, 204, such as, for example, an infrared (IR)-based communicationlink. Power may be supplied to the instrument interface circuit 240using, for example, a low-dropout voltage regulator powered by anisolation transformer driven from the non-isolated stage 204.

In one form, the instrument interface circuit 240 may comprise a logicdevice 242 (e.g., logic circuit, programmable logic circuit, PGA, FPGA,PLD) in communication with a signal conditioning circuit 244. The signalconditioning circuit 244 may be configured to receive a periodic signalfrom the logic circuit 242 (e.g., a 2 kHz square wave) to generate abipolar interrogation signal having an identical frequency. Theinterrogation signal may be generated, for example, using a bipolarcurrent source fed by a differential amplifier. The interrogation signalmay be communicated to a surgical instrument control circuit (e.g., byusing a conductive pair in a cable that connects the generator 200 tothe surgical instrument) and monitored to determine a state orconfiguration of the control circuit. The control circuit may comprise anumber of switches, resistors and/or diodes to modify one or morecharacteristics (e.g., amplitude, rectification) of the interrogationsignal such that a state or configuration of the control circuit isuniquely discernable based on the one or more characteristics. In oneform, for example, the signal conditioning circuit 244 may comprise anADC for generating samples of a voltage signal appearing across inputsof the control circuit resulting from passage of interrogation signaltherethrough. The logic device 242 (or a component of the non-isolatedstage 204) may then determine the state or configuration of the controlcircuit based on the ADC samples.

In one form, the instrument interface circuit 240 may comprise a firstdata circuit interface 246 to enable information exchange between thelogic circuit 242 (or other element of the instrument interface circuit240) and a first data circuit disposed in or otherwise associated with asurgical instrument. In certain forms, for example, a first data circuit136 (FIG. 2) may be disposed in a cable integrally attached to asurgical instrument hand piece, or in an adaptor for interfacing aspecific surgical instrument type or model with the generator 200. Thedata circuit 136 may be implemented in any suitable manner and maycommunicate with the generator according to any suitable protocolincluding, for example, as described herein with respect to the datacircuit 136. In certain forms, the first data circuit may comprise anon-volatile storage device, such as an electrically erasableprogrammable read-only memory (EEPROM) device. In certain forms andreferring again to FIG. 5, the first data circuit interface 246 may beimplemented separately from the logic device 242 and comprise suitablecircuitry (e.g., discrete logic devices, a processor) to enablecommunication between the programmable logic device 242 and the firstdata circuit. In other forms, the first data circuit interface 246 maybe integral with the logic device 242.

In certain forms, the first data circuit 136 may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information. This informationmay be read by the instrument interface circuit 240 (e.g., by the logicdevice 242), transferred to a component of the non-isolated stage 204(e.g., to logic device 216, DSP processor 222 and/or UI processor 236)for presentation to a user via an output device 110 and/or forcontrolling a function or operation of the generator 200. Additionally,any type of information may be communicated to first data circuit 136for storage therein via the first data circuit interface 246 (e.g.,using the logic device 242). Such information may comprise, for example,an updated number of operations in which the surgical instrument hasbeen used and/or dates and/or times of its usage.

As discussed previously, a surgical instrument may be detachable from ahand piece (e.g., instrument 108 may be detachable from hand piece 109)to promote instrument interchangeability and/or disposability. In suchcases, conventional generators may be limited in their ability torecognize particular instrument configurations being used and tooptimize control and diagnostic processes accordingly. The addition ofreadable data circuits to surgical instrument instruments to addressthis issue is problematic from a compatibility standpoint, however. Forexample, designing a surgical instrument to remain backwardly compatiblewith generators that lack the requisite data reading functionality maybe impractical due to, for example, differing signal schemes, designcomplexity, and cost. Forms of instruments discussed herein addressthese concerns by using data circuits that may be implemented inexisting surgical instruments economically and with minimal designchanges to preserve compatibility of the surgical instruments withcurrent generator platforms.

Additionally, forms of the generator 200 may enable communication withinstrument-based data circuits. For example, the generator 200 may beconfigured to communicate with a second data circuit 138 contained in aninstrument (e.g., instrument 108) of a surgical instrument (FIG. 2). Insome forms, the second data circuit 138 may be implemented in a manysimilar to that of the data circuit 136 described herein. The instrumentinterface circuit 240 may comprise a second data circuit interface 248to enable this communication. In one form, the second data circuitinterface 248 may comprise a tri-state digital interface, although otherinterfaces may also be used. In certain forms, the second data circuitmay generally be any circuit for transmitting and/or receiving data. Inone form, for example, the second data circuit may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information.

In some forms, the second data circuit 138 may store information aboutthe electrical and/or ultrasonic properties of an associated transducer120, end effector 125, or ultrasonic drive system. For example, thefirst data circuit 136 may indicate a burn-in frequency slope, asdescribed herein. Additionally or alternatively, any type of informationmay be communicated to second data circuit for storage therein via thesecond data circuit interface 248 (e.g., using the logic device 242).Such information may comprise, for example, an updated number ofoperations in which the instrument has been used and/or dates and/ortimes of its usage. In certain forms, the second data circuit maytransmit data acquired by one or more sensors (e.g., an instrument-basedtemperature sensor). In certain forms, the second data circuit mayreceive data from the generator 200 and provide an indication to a user(e.g., an LED indication or other visible indication) based on thereceived data.

In certain forms, the second data circuit and the second data circuitinterface 248 may be configured such that communication between thelogic device 242 and the second data circuit can be effected without theneed to provide additional conductors for this purpose (e.g., dedicatedconductors of a cable connecting a hand piece to the generator 200). Inone form, for example, information may be communicated to and from thesecond data circuit using a 1-wire bus communication scheme implementedon existing cabling, such as one of the conductors used transmitinterrogation signals from the signal conditioning circuit 244 to acontrol circuit in a hand piece. In this way, design changes ormodifications to the surgical instrument that might otherwise benecessary are minimized or reduced. Moreover, because different types ofcommunications implemented over a common physical channel can befrequency-band separated, the presence of a second data circuit may be“invisible” to generators that do not have the requisite data readingfunctionality, thus enabling backward compatibility of the surgicalinstrument.

In certain forms, the isolated stage 202 may comprise at least oneblocking capacitor 250-1 connected to the drive signal output 210 b toprevent passage of DC current to a patient. A single blocking capacitormay be required to comply with medical regulations or standards, forexample. While failure in single-capacitor designs is relativelyuncommon, such failure may nonetheless have negative consequences. Inone form, a second blocking capacitor 250-2 may be provided in serieswith the blocking capacitor 250-1, with current leakage from a pointbetween the blocking capacitors 250-1, 250-2 being monitored by, forexample, an ADC 252 for sampling a voltage induced by leakage current.The samples may be received by the logic circuit 242, for example. Basedchanges in the leakage current (as indicated by the voltage samples inthe form of FIG. 5), the generator 200 may determine when at least oneof the blocking capacitors 250-1, 250-2 has failed. Accordingly, theform of FIG. 5 provides a benefit over single-capacitor designs having asingle point of failure.

In certain forms, the non-isolated stage 204 may comprise a power supply254 for outputting DC power at a suitable voltage and current. The powersupply may comprise, for example, a 400 W power supply for outputting a48 VDC system voltage. The power supply 254 may further comprise one ormore DC/DC voltage converters 256 for receiving the output of the powersupply to generate DC outputs at the voltages and currents required bythe various components of the generator 200. As discussed above inconnection with the controller 238, one or more of the DC/DC voltageconverters 256 may receive an input from the controller 238 whenactivation of the “on/off” input device 112 by a user is detected by thecontroller 238 to enable operation of, or wake, the DC/DC voltageconverters 256.

Having described operational details of various forms of the surgicalsystem 10 (FIG. 1) operations for the above surgical system 10 may befurther described generally in terms of a process for cutting andcoagulating tissue employing a surgical instrument comprising an inputdevice 112 and the generator 100. Although a particular process isdescribed in connection with the operational details, it can beappreciated that the process merely provides an example of how thegeneral functionality described herein can be implemented by thesurgical system 10. Further, the given process does not necessarily haveto be executed in the order presented herein unless otherwise indicated.As previously discussed, the input devices 112 may be employed toprogram the output (e.g., impedance, current, voltage, frequency) of thesurgical instruments 104, 106, 108 (FIG. 1).

FIG. 6 illustrates one form of a drive system 32 of a generator 300,which is one form of the generator 100 (FIGS. 1-3). The generator 300 isconfigured to provide an ultrasonic electrical signal for driving anultrasonic transducer (e.g., ultrasonic transducer 120 FIGS. 1-3), alsoreferred to as a drive signal. The generator 300 is similar to and maybe interchangeable with the generators 100, 200 (FIGS. 1-3 and 5). Thedrive system 32 is flexible and can create an ultrasonic electricaldrive signal 416 at a desired frequency and power level setting fordriving the ultrasonic transducer 50. In various forms, the generator300 may comprise several separate functional elements, such as modulesand/or blocks. Although certain modules and/or blocks may be describedby way of example, it can be appreciated that a greater or lesser numberof modules and/or blocks may be used and still fall within the scope ofthe forms. Further, although various forms may be described in terms ofmodules and/or blocks to facilitate description, such modules and/orblocks may be implemented by one or more hardware components, e.g.,processors, Digital Signal Processors (DSPs), Programmable Logic Devices(PLDs), Application Specific Integrated Circuits (ASICs), circuits,registers and/or software components, e.g., programs, subroutines, logicand/or combinations of hardware and software components.

In one form, the generator 300 drive system 32 may comprise one or moreembedded applications implemented as firmware, software, hardware, orany combination thereof. The generator 300 drive system 32 may comprisevarious executable modules such as software, programs, data, drivers,application program interfaces (APIs), and so forth. The firmware may bestored in nonvolatile memory (NVM), such as in bit-masked read-onlymemory (ROM) or flash memory. In various implementations, storing thefirmware in ROM may preserve flash memory. The NVM may comprise othertypes of memory including, for example, programmable ROM (PROM),erasable programmable ROM (EPROM), electrically erasable programmableROM (EEPROM), or battery backed random-access memory (RAM) such asdynamic RAM (DRAM), Double-Data-Rate DRAM (DDRAM), and/or synchronousDRAM (SDRAM).

In one form, the generator 300 drive system 32 comprises a hardwarecomponent implemented as a processor 308 for executing programinstructions for monitoring various measurable characteristics of theultrasonic surgical instrument 104 (FIG. 1) and generating a stepfunction output signal for driving the ultrasonic transducer in cuttingand/or coagulation operating modes. It will be appreciated by thoseskilled in the art that the generator 300 and the drive system 32 maycomprise additional or fewer components and only a simplified version ofthe generator 300 and the drive system 32 are described herein forconciseness and clarity. In various forms, as previously discussed, thehardware component may be implemented as a DSP, PLD, ASIC, circuits,and/or registers. In one form, the processor 308 may be configured tostore and execute computer software program instructions to generate thestep function output signals for driving various components of theultrasonic surgical instrument 104, such as a transducer, an endeffector, and/or a blade.

In one form, under control of one or more software program routines, theprocessor 308 executes the methods in accordance with the describedforms to generate a step function formed by a stepwise waveform of drivesignals comprising current (I), voltage (V), and/or frequency (f) forvarious time intervals or periods (T). The stepwise waveforms of thedrive signals may be generated by forming a piecewise linear combinationof constant functions over a plurality of time intervals created bystepping the generator 30 drive signals, e.g., output drive current (I),voltage (V), and/or frequency (f). The time intervals or periods (T) maybe predetermined (e.g., fixed and/or programmed by the user) or may bevariable. Variable time intervals may be defined by setting the drivesignal to a first value and maintaining the drive signal at that valueuntil a change is detected in a monitored characteristic. Examples ofmonitored characteristics may comprise, for example, transducerimpedance, tissue impedance, tissue heating, tissue transection, tissuecoagulation, and the like. The ultrasonic drive signals generated by thegenerator 300 include, without limitation, ultrasonic drive signalscapable of exciting the ultrasonic transducer 50 in various vibratorymodes such as, for example, the primary longitudinal mode and harmonicsthereof as well flexural and torsional vibratory modes.

In one form, the executable modules comprise one or more algorithm(s)310 stored in memory that when executed causes the processor 308 togenerate a step function formed by a stepwise waveform of drive signalscomprising current (I), voltage (V), and/or frequency (f) for varioustime intervals or periods (T). The stepwise waveforms of the drivesignals may be generated by forming a piecewise linear combination ofconstant functions over two or more time intervals created by steppingthe output drive current (I), voltage (V), and/or frequency (f) of thegenerator 300. The drive signals may be generated either forpredetermined fixed time intervals or periods (T) of time or variabletime intervals or periods of time in accordance with the one or morealgorithm(s) 310. Under control of the processor 308, the generator 100steps (e.g., increment or decrement) the current (I), voltage (V),and/or frequency (f) up or down at a particular resolution for apredetermined period (T) or until a predetermined condition is detected,such as a change in a monitored characteristic (e.g., transducerimpedance, tissue impedance). The steps can change in programmedincrements or decrements. If other steps are desired, the generator 300can increase or decrease the step adaptively based on measured systemcharacteristics.

In operation, the user can program the operation of the generator 300using the input device 312 located on the front panel of the generator300 console. The input device 312 may comprise any suitable device thatgenerates signals 408 that can be applied to the processor 308 tocontrol the operation of the generator 300. In various forms, the inputdevice 406 includes buttons, switches, thumbwheels, keyboard, keypad,touch screen monitor, pointing device, remote connection to a generalpurpose or dedicated computer. In other forms, the input device 312 maycomprise a suitable user interface. Accordingly, by way of the inputdevice 312, the user can set or program the current (I), voltage (V),frequency (f), and/or period (T) for programming the step functionoutput of the generator 300. The processor 308 then displays theselected power level by sending a signal on line 312 to an outputindicator 318.

In various forms, the output indicator 318 may provide visual, audible,and/or tactile feedback to the surgeon to indicate the status of asurgical procedure, such as, for example, when tissue cutting andcoagulating is complete based on a measured characteristic of theultrasonic surgical instrument 104, e.g., transducer impedance, tissueimpedance, or other measurements as subsequently described. By way ofexample, and not limitation, visual feedback comprises any type ofvisual indication device including incandescent lamps or light emittingdiodes (LEDs), graphical user interface, display, analog indicator,digital indicator, bar graph display, digital alphanumeric display. Byway of example, and not limitation, audible feedback comprises any typeof buzzer, computer generated tone, computerized speech, voice userinterface (VUI) to interact with computers through a voice/speechplatform. By way of example, and not limitation, tactile feedbackcomprises any type of vibratory feedback provided through an instrumenthousing handle assembly.

In one form, the processor 308 may be configured or programmed togenerate a digital current signal 320 and a digital frequency signal322. These signals 320, 322 are applied to a digital synthesis circuitsuch as the direct digital synthesizer (DDS) circuit 324 (see e.g.,FIGS. 13, 14) to adjust the amplitude and the frequency (f) of thecurrent output signal 304 to the transducer. The output of the DDScircuit 324 is applied to an amplifier 326 whose output is applied to atransformer 328. The output of the transformer 328 is the signal 304applied to the ultrasonic transducer, which is coupled to a blade by wayof a waveguide. The output of the DDS circuit 324 may be stored in onemore memory circuits including volatile (RAM) and non-volatile (ROM)memory circuits.

In one form, the generator 300 comprises one or more measurement modulesor components that may be configured to monitor measurablecharacteristics of the ultrasonic instrument 104 (FIGS. 1-2) or thecombination electrosurgical/ultrasonic instrument 108 (FIGS. 1-3). Inthe illustrated form, the processor 308 may be employed to monitor andcalculate system characteristics. As shown, the processor 308 measuresthe impedance Z of the transducer by monitoring the current supplied tothe transducer 50 and the voltage applied to the transducer. In oneform, a current sense circuit 330 is employed to sense the currentflowing through the transducer and a voltage sense circuit 332 isemployed to sense the output voltage applied to the transducer 50. Thesesignals may be applied to the analog-to-digital converter 336 (ADC) viaan analog multiplexer 334 circuit or switching circuit arrangement. Theanalog multiplexer 334 routes the appropriate analog signal to the ADC336 for conversion. In other forms, multiple ADCs 336 may be employedfor each measured characteristic instead of the multiplexer 334 circuit.The processor 308 receives the digital output 338 of the ADC 336 andcalculates the transducer impedance Z based on the measured values ofcurrent and voltage. The processor 308 adjusts the output drive signal338 such that it can generate a desired power versus load curve. Inaccordance with programmed algorithms 310, the processor 308 can stepthe drive signal 301, e.g., the current or frequency, in any suitableincrement or decrement in response to the transducer impedance Z.

Having described operational details of various forms of the surgicalsystem 10 operations for the above surgical system 10 may be furtherdescribed in terms of a process for cutting and coagulating a bloodvessel employing a surgical instrument comprising the input device 112and the transducer impedance measurement capabilities described withreference to FIG. 6. Although a particular process is described inconnection with the operational details, it can be appreciated that theprocess merely provides an example of how the general functionalitydescribed herein can be implemented by the surgical system 10. Further,the given process does not necessarily have to be executed in the orderpresented herein unless otherwise indicated.

FIG. 7 illustrates one aspect of a drive system 402 of the generator400, which is one form of the generator 100 (FIGS. 1-3). The generator400 comprises a tissue impedance module 442. The drive system 402 isconfigured to generate the ultrasonic electrical drive signal 404 todrive the ultrasonic transducer 406. In one aspect, the tissue impedancemodule 442 may be configured to measure the impedance Zt of tissuegrasped between the blade 440 and the clamp arm assembly 444. The tissueimpedance module 442 comprises an RF oscillator 446, a voltage sensingcircuit 448, and a current sensing circuit 450. The voltage and currentsensing circuits 448, 450 respond to the RF voltage Vrf applied to theblade 440 electrode and the RF current irf flowing through the blade 440electrode, the tissue, and the conductive portion of the clamp armassembly 444. The sensed voltage Vrf and current Irf are converted todigital form by the ADC 436 via the analog multiplexer 434. Theprocessor 308 receives the digitized output 438 of the ADC 436 anddetermines the tissue impedance Zt by calculating the ratio of the RFvoltage Vrf to current Irf measured by the voltage sense circuit 448 andthe current sense circuit 450. In one aspect, the transection of theinner muscle layer and the tissue may be detected by sensing the tissueimpedance Zt. Accordingly, detection of the tissue impedance Zt may beintegrated with an automated process for separating the inner musclelayer from the outer adventitia layer prior to transecting the tissuewithout causing a significant amount of heating, which normally occursat resonance.

In one form, the RF voltage Vrf applied to the blade 440 electrode andthe RF current Irf flowing through the blade 440 electrode, the tissue,and the conductive portion of the clamp arm assembly 444 are suitablefor vessel sealing and/or dissecting. Thus, the RF power output of thegenerator 400 can be selected for non-therapeutic functions such astissue impedance measurements as well as therapeutic functions such asvessel sealing and/or dissection. It will be appreciated, that in thecontext of the present disclosure, the ultrasonic and the RFelectrosurgical energies can be supplied by the generator eitherindividually or simultaneously.

In various forms, feedback is provided by the output indicator 418 shownin FIGS. 6 and 7. The output indicator 418 is particularly useful inapplications where the tissue being manipulated by the end effector isout of the user's field of view and the user cannot see when a change ofstate occurs in the tissue. The output indicator 418 communicates to theuser that a change in tissue state has occurred. As previouslydiscussed, the output indicator 418 may be configured to provide varioustypes of feedback to the user including, without limitation, visual,audible, and/or tactile feedback to indicate to the user (e.g., surgeon,clinician) that the tissue has undergone a change of state or conditionof the tissue. By way of example, and not limitation, as previouslydiscussed, visual feedback comprises any type of visual indicationdevice including incandescent lamps or LEDs, graphical user interface,display, analog indicator, digital indicator, bar graph display, digitalalphanumeric display. By way of example, and not limitation, audiblefeedback comprises any type of buzzer, computer generated tone,computerized speech, VUI to interact with computers through avoice/speech platform. By way of example, and not limitation, tactilefeedback comprises any type of vibratory feedback provided through theinstrument housing handle assembly. The change of state of the tissuemay be determined based on transducer and tissue impedance measurementsas previously described, or based on voltage, current, and frequencymeasurements.

In one form, the various executable modules (e.g., algorithms)comprising computer readable instructions can be executed by theprocessor 401 (FIGS. 6, 7) portion of the generator 300, 400 (FIGS. 6,7). In various forms, the operations described with respect to thealgorithms may be implemented as one or more software components, e.g.,programs, subroutines, logic; one or more hardware components, e.g.,processors, DSPs, PLDs, ASICs, circuits, registers; and/or combinationsof software and hardware. In one form, the executable instructions toperform the algorithms may be stored in memory. When executed, theinstructions cause the processor 308 to determine a change in tissuestate provide feedback to the user by way of the output indicator 418.In accordance with such executable instructions, the processor 308monitors and evaluates the voltage, current, and/or frequency signalsamples available from the generator 400 and according to the evaluationof such signal samples determines whether a change in tissue state hasoccurred. As further described below, a change in tissue state may bedetermined based on the type of ultrasonic instrument and the powerlevel that the instrument is energized at. In response to the feedback,the operational mode of the ultrasonic surgical instrument 104 may becontrolled by the user or may be automatically or semi-automaticallycontrolled.

FIG. 8 illustrates an example of a generator 500, which is one form ofthe generator 100 (FIGS. 1-3). The generator 500 is configured todeliver multiple energy modalities to a surgical instrument. Thegenerator 500 includes functionalities of the generators 200, 300, 400shown in FIGS. 5-7. The generator 500 provides radio frequency andultrasonic signals for delivering energy to a surgical instrument. Theradio frequency and ultrasonic signals may be provided alone or incombination and may be provided simultaneously. As noted above, at leastone generator output can deliver multiple energy modalities (e.g.,ultrasonic, bipolar or monopolar RF, irreversible and/or reversibleelectroporation, and/or microwave energy, among others) through a singleport and these signals can be delivered separately or simultaneously tothe end effector to treat tissue. The generator 500 comprises aprocessor 502 coupled to a waveform generator 504. The processor 502 andwaveform generator 504 are configured to generate a variety of signalwaveforms based on information stored in a memory coupled to theprocessor 502, not shown for clarity of disclosure. The digitalinformation associated with a waveform is provided to the waveformgenerator 504 which includes one or more digital-to-analog (DAC)converters to convert the digital input into an analog output. Theanalog output is fed to an amplifier 1106 for signal conditioning andamplification. The conditioned and amplified output of the amplifier 506is coupled to a power transformer 508. The signals are coupled acrossthe power transformer 508 to the secondary side, which is in the patientisolation side. A first signal of a first energy modality is provided tothe surgical instrument between the terminals labeled ENERGY1 andRETURN. A second signal of a second energy modality is coupled across acapacitor 510 and is provided to the surgical instrument between theterminals labeled ENERGY2 and RETURN. It will be appreciated that morethan two energy modalities may be output and thus the subscript “n” maybe used to designate that up to n ENERGYn terminals may be provided,where n is a positive integer greater than 1. It also will beappreciated that up to “n” return paths RETURNn may be provided withoutdeparting from the scope of the present disclosure.

A first voltage sensing circuit 512 is coupled across the terminalslabeled ENERGY1 and the RETURN path to measure the output voltagetherebetween. A second voltage sensing circuit 524 is coupled across theterminals labeled ENERGY2 and the RETURN path to measure the outputvoltage therebetween. A current sensing circuit 514 is disposed inseries with the RETURN leg of the secondary side of the powertransformer 508 as shown to measure the output current for either energymodality. If different return paths are provided for each energymodality, then a separate current sensing circuit should be provided ineach return leg. The outputs of the first and second voltage sensingcircuits 512, 524 are provided to respective isolation transformers 516,522 and the output of the current sensing circuit 514 is provided toanother isolation transformer 518. The outputs of the isolationtransformers 516, 518, 522 on the primary side of the power transformer508 (non-patient-isolated side) are provided to a one or moreanalog-to-digital converters 526 (ADC). The digitized output of the ADC526 is provided to the processor 502 for further processing andcomputation. The output voltages and output current feedback informationcan be employed to adjust the output voltage and current provided to thesurgical instrument and to compute output impedance, among otherparameters.

Input/output communications between the processor 502 and patientisolated circuits is provided through an interface circuit 520. Sensorsalso may be in electrical communication with the processor 502 by way ofthe interface 520.

In one aspect, the impedance may be determined by the processor 502 bydividing the output of either the first voltage sensing circuit 512coupled across the terminals labeled ENERGY1/RETURN or the secondvoltage sensing circuit 524 coupled across the terminals labeledENERGY2/RETURN by the output of the current sensing circuit 514 disposedin series with the RETURN leg of the secondary side of the powertransformer 508. The outputs of the first and second voltage sensingcircuits 512, 524 are provided to separate isolations transformers 516,522 and the output of the current sensing circuit 514 is provided toanother isolation transformer 516. The digitized voltage and currentsensing measurements from the ADC 526 are provided the processor 502 forcomputing impedance. As an example, the first energy modality ENERGY1may be ultrasonic energy and the second energy modality ENERGY2 may beRF energy. Nevertheless, in addition to ultrasonic and bipolar ormonopolar RF energy modalities, other energy modalities includeirreversible and/or reversible electroporation and/or microwave energy,among others. Also, although the example illustrated in FIG. 8 shows asingle return path RETURN may be provided for two or more energymodalities, in other aspects multiple return paths RETURNn may beprovided for each energy modality ENERGYn. Thus, as described herein,the ultrasonic transducer impedance may be measured by dividing theoutput of the first voltage sensing circuit 512 by the current sensingcircuit 514 and the tissue impedance may be measured by dividing theoutput of the second voltage sensing circuit 524 by the current sensingcircuit 514.

As shown in FIG. 8, the generator 500 comprising at least one outputport can include a power transformer 508 with a single output and withmultiple taps to provide power in the form of one or more energymodalities, such as ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers, for example, to the end effector depending on the type oftreatment of tissue being performed. For example, the generator 500 candeliver energy with higher voltage and lower current to drive anultrasonic transducer, with lower voltage and higher current to drive RFelectrodes for sealing tissue, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. The output waveform from the generator 500 can be steered,switched, or filtered to provide the frequency to the end effector ofthe surgical instrument. The connection of an ultrasonic transducer tothe generator 500 output would be preferably located between the outputlabeled ENERGY1 and RETURN as shown in FIG. 8. An In one example, aconnection of RF bipolar electrodes to the generator 500 output would bepreferably located between the output labeled ENERGY2 and RETURN. In thecase of monopolar output, the preferred connections would be activeelectrode (e.g., pencil or other probe) to the ENERGY2 output and asuitable return pad connected to the RETURN output.

In other aspects, the generators 100, 200, 300, 400, 500 described inconnection with FIGS. 1-3 and 5-8, the ultrasonic generator drivecircuit 114, and/or electrosurgery/RF drive circuit 116 as described inconnection with FIG. 3 may be formed integrally with any one of thesurgical instruments 104, 106, 108 described in connection with FIGS. 1and 2. Accordingly, any of the processors, digital signal processors,circuits, controllers, logic devices, ADCs, DACs, amplifiers,converters, transformers, signal conditioners, data interface circuits,current and voltage sensing circuits, direct digital synthesis circuits,multiplexer (analog or digital), waveform generators, RF generators,memory, and the like, described in connection with any one of thegenerators 100, 200, 300, 400, 500 can be located within the surgicalinstruments 104, 106, 108 or may be located remotely from the surgicalinstruments 104, 106, 108 and coupled to the surgical instruments viawired and/or wireless electrical connections.

FIG. 9 shows a diagram of an electrosurgical system 9000 that allows fortwo ports on a generator 9001 and accounts for electrical isolationbetween two surgical instruments 9007, 9008. A scheme is provided forelectrical isolation between the two instruments 9007, 9008 as they arelocated on the same patient isolation circuit. According to theconfiguration shown in FIG. 9, unintended electrical power feedback isprevented through the electrosurgical system 9000. In various aspects,power FETs or relays are used to electrically isolate all power linesfor each instrument 9007, 9008. According to one aspect, the power FETsor relays are controlled by a 1-wire communication protocol.

As shown in FIG. 9, a generator 9001, which is one form of the generator100 (FIGS. 1-3), is coupled to a power switching mechanism 9003 and acommunications system 9005. In one aspect, the power switching mechanism9003 comprises power FETs, such as MOSFETs, and/or relays, such aselectromechanical relays. In one aspect, the communications system 9005comprises components for D1 emulation, FPGA expansion, and time slicingfunctionalities. The power switching mechanism 9003 is coupled to thecommunications system 9005. Each of the power switching mechanism 9003and the communications system 9005 are coupled to surgical instruments9007, 9008 (labeled device 1 and device 2). Each of surgical instruments9007, 9008 comprise components for a combined RF and Ultrasonic energyinput 9011, 9012, HSW 1-wire protocol interface 9013, 9014, HP 1-wireprotocol interface 9015, 9016, and a presence resistor interface 9017,9018. The power switching mechanism 9003 is coupled to the RF andUltrasonic energy input 9011, 9012 for each of surgical instruments9007, 9008. The communications system 9005 is coupled to the HSW 1-wireinterface 9013, 9014, the HP 1-wire interface 9015, 9016, and presenceinterface 9017, 9018 for each of surgical instruments 9007, 9008. Whiletwo surgical instruments are shown in FIG. 9, there may be more than twodevices according to various aspects.

FIGS. 10-12 illustrate aspects of an interface with a generator tosupport two instruments simultaneously that allows the instruments toquickly switch between active/inactive by a user in a sterile field.FIGS. 10-12 describe multiple communication schemes which would allowfor a super cap/battery charger and dual surgical instruments. Theaspects of FIGS. 10-12 allow for communications to two surgicalinstruments in the surgical field from a generator with at least onecommunications port and allow for an operator in sterile field to switchbetween devices, for example, without modifying the surgicalinstruments.

FIG. 10 is a diagram of a communications architecture of system 1001comprising a generator 1003, which is one form of the generator 100(FIGS. 1-3), and surgical instruments 9007, 9008, which are shown inFIG. 9. According to FIG. 10, the generator 9001 is configured fordelivering multiple energy modalities to a plurality of surgicalinstruments. As discussed herein the various energy modalities include,without limitation, ultrasonic, bipolar or monopolar RF, reversibleand/or irreversible electroporation, and/or microwave energy modalities.The generator 9001 comprises a combined energy modality power output1005, a communications interface 1007, and a presence interface 1049.According to the aspect of FIG. 10, the communications interface 1007comprises an handswitch (HSVV) serial interface 1011 and an handpiece(HP) serial interface 1013. The serial interfaces 1011, 1013 maycomprise I²C, half duplex SPI, and/or Universal Asynchronous ReceiverTransmitter (UART) components and/or functionalities. The generator 1003provides the combined energy modalities power output 1005 to an adapter1015, for example, a pass-through charger (PTC). The adapter 1015comprises energy storage circuit 1071, control circuit 1019, a uniquepresence element 1021, and associated circuit discussed below. In oneaspect, the presence element 1021 is a resistor. In another aspect, thepresence element 1021 may be a bar code, Quick Response (QR) code, orsimilar code, or a value stored in memory such as, for example, a valuestored in NVM. The presence element 1021 may be unique to the adapter1015 so that, in the event that another adapter that did not use thesame wire interfaces could not be used with the unique presence element1021. In one aspect, the unique presence element 1021 is a resistor. Theenergy storage circuit 1071 comprises a switching mechanism 1023, energystorage device 1025, storage control 1027, storage monitoring component1029, and a device power monitoring component 1031. The control circuit1019 may comprise a processor, FPGA, PLD, CPLD, microcontroller, DSP,and/or ASIC, for example. According to the aspect shown in FIG. 10, anFPGA or microcontroller would act as an extension of an existing,similar computing hardware and allows for information to be relayed fromon entity to another entity.

The switching mechanism 1023 is configured to receive the combinedenergy power output 1005 from the generator 1003 and it may be providedto the energy storage device 1025, surgical instrument 9007, and/orsurgical instrument 9008. The device power monitoring component 1031 iscoupled to the channels for the energy storage device 1025, surgicalinstrument 9007, surgical instrument 9008, and may monitor where poweris flowing. The control circuit 1019 comprises communication interface1033 coupled to the handswitch serial interface 1011 and an handpieceserial interface 1013 of the generator 1003. The control circuit 1019 isalso coupled to the storage control 1027, storage monitoring component1029, and device power monitoring component 1031 of the energy storagecircuit 1071.

The control circuit 1019 further comprises a serial master interface1035 that is coupled to handswitch (HSVV) #1 circuit 1037 and handswitch(HSVV) #2 circuit 1038, includes generation and ADC, a form of memory(non volatile or flash) 1039, along with a method for detecting thepresence of an attached instrument (Presence) #1 circuit 1041 andPresence #2 circuit 1042, which includes a voltage or current source andADC. The serial master interface 1035 also includes handswitch NVMbypass channels, which couple the serial master interface 1035 to theoutputs of the handswitch #1 circuit 1037 and the handswitch #2 circuit1038, respectively. The handswitch #1 circuit 1037 and handswitch #2circuit 1038 are coupled to the handswitch serial interfaces 9013, 9014of the surgical instruments 9007, 9008, respectively. The serial masterinterface 1035 further includes handpiece serial channels that arecoupled to the handpiece serial interfaces 9015, 9016 of the surgicalinstruments 9007, 9008, respectively. Further, Presence #1 and Presence#2 circuits 1041, 1042 are coupled to the presence interfaces 9017, 9018of the surgical instruments 9007, 9008, respectively.

The system 1001 allows the control circuit 1019, such as an FPGA, tocommunicate with more surgical instruments using adapter 1015, whichacts as an expansion adapter device. According to various aspects, theadapter 1015 expands the Input/Output (I/O) capability of the generator1003 control. The adapter 1015 may function as an extension of thecentral processing unit that allows commands to be transmitted over abus between the adapter 1015 and the generator 1003 and unpacks thecommands and use them to bit-bang over interfaces or to controlconnected analog circuit. The adapter 1015 also allows for reading inADC values from connected surgical instruments 9007, 9008 and relay thisinformation to the generator control and the generator control wouldthen control the two surgical instruments 9007, 9008. According tovarious aspects, the generator 1003 may control the surgical instruments9007, 9008 as two separate state machines and may store the data.

Existing interfaces (the handswitch serial interface 1011 and thehandpiece serial interface 1013 lines from generator 1003) may be usedin a two-wire communication protocol that enables the generator 1003control to communicate with multiple surgical instruments connected to adual port interface, similar to the topology of a universal serial bus(USB) hub.

This allows interfacing with two separate surgical instrumentssimultaneously. The system 1001 may be able to generate and read handswitch waveforms and be able to handle incoming handpiece serial buses.It would also monitor two separate presence elements in the surgicalinstruments 9007, 9008. In one aspect, the system 1001 may include aunique presence element and may have its own NVM.

Further, according to various aspects, the control circuit 1019 may becontrolled by the generator 1003. The communication between the adapter1015 and connected surgical instruments 9007, 9008 may be relayed togenerator control. The generator 1003 would control the waveformgeneration circuit connected to the adapter 1015 to simultaneouslygenerate handswitch signals for surgical instruments 9007, 9008.

The system 1001 may allow surgical instrument activity that can besimultaneously detected/monitored for two surgical instruments, evenduring activation. If upgradeable, the adapter 1015 would be capable ofhandling new surgical instrument communications protocols. Further, fastswitching between surgical instruments may be accomplished.

FIG. 11 illustrates a communication architecture of system 1101 of agenerator 1103, which is one form of the generator 100 (FIGS. 1-3), andsurgical instruments 9007, 9008 shown in FIG. 9. According to FIG. 11,the generator 1103 is configured for delivering multiple energymodalities to a plurality of surgical instruments. As discussed hereinthe various energy modalities include, without limitation, ultrasonic,bipolar or monopolar RF, reversible and/or irreversible electroporation,and/or microwave energy modalities. As shown in FIG. 11, the generator1103 comprises a combined energy modality power output 1105, anhandswitch (HSVV) serial interface 1111, a handpiece (HP) serialinterface 1113, and a presence interface 1109. The generator 1103provides the power output 1105 to an adapter 1115. According to theaspect shown in FIG. 11, communications between the adapter 1115 and thegenerator 1103 may be done solely through serial interfaces, such as thehandswitch serial and handpiece serial interfaces 1111, 1113. Thegenerator 1103 may use these handswitch and handpiece serial interfaces1111, 1113 to control which instrument the generator 1103 iscommunicating with. Further, switching between instruments could occurbetween handswitch frames or at a much slower rate.

The adapter 1115 comprises energy storage circuit 1117, control circuit1119, an adapter memory 1121 (e.g., a NVM such as an EEPROM), a serialprogrammable input/output (PIO) integrated circuit 1133, an handswitchSwitching Mechanism 1135, an handpiece Switching Mechanism 1137, aPresence Switching Mechanism 1139, and a Generic Adapter 1141. In oneaspect, the serial PIO integrated circuit 1133 may be an addressableswitch. The energy storage circuitry 1117 comprises a switchingmechanism 1123, energy storage device 1125, storage control component1127, storage monitoring component 1129, and a device power monitoringcomponent 1131. The control circuit 1119 may comprise a processor, FPGA,CPLD, PLD, microcontroller, DSP, and/or an ASIC, for example. Accordingto the aspect of FIG. 11, an FPGA or microcontroller may have limitedfunctionality and may solely comprise functionality for monitoring andcommunicating energy storage.

The switching mechanism 1123 is configured to receive the combinedenergy power output 1105 from the generator 1103 and it may be providedto the energy storage device 1125, surgical instrument 9007, and/orsurgical instrument 9008. The device power monitoring component 1131 iscoupled to the channels for the energy storage device 1125, surgicalinstrument 9007, surgical instrument 9008, and may monitor where poweris flowing.

The control circuit 1119 is coupled to the serial PIO integrated circuit1133 and the serial PIO integrated circuit 1133 is coupled to thehandpiece serial interface 1113 of the generator 1103. The controlcircuit 1119 may receive information regarding charger status flags andswitching controls from the serial PIO integrated circuit 1133. Further,the control circuit 1119 is coupled to the handswitch switchingmechanism 1135, the handpiece switching mechanism 1137, and the presenceswitching mechanism 1139. According to the aspect of FIG. 11, thecontrol circuit 1119 may be coupled to the handswitch (HSVV) switchingmechanism 1135 and the handpiece switching mechanism 1137 for deviceselection and the control circuit 1119 may be coupled to the presenceswitching Mechanism 1139 for presence selection.

The handswitch switching mechanism 1135, the handpiece switchingmechanism 1137, and the presence switching mechanism 1139 are coupled tothe handswitch serial interface 1111, the handpiece serial interface1113, and the presence interface 1109 of generator 1103, respectively.Further, the handswitch switching mechanism 1135, the handpieceswitching mechanism 1137, and the presence switching mechanism 1139 arecoupled to the handswitch serial interfaces 9013, 9014, the handpieceserial interfaces 9015, 9016, and the presence interfaces 9017, 9018 ofthe surgical instruments 9007, 9008, respectively. Further, the presenceswitching mechanism 1139 is coupled to the generic adapter 1141.

The generator 1103 switches between monitoring the surgical instruments9007, 9008. According to various aspects, this switching may require thegenerator 1103 control to keep track of surgical instruments 9007, 9008and run two separate state machines. The control circuit 1119 will needto remember which surgical instruments are connected, so that it canoutput an appropriate waveform to the ports where appropriate. Thegenerator 1103 may generate/monitor hand switch signals, as well ascommunicating with serial NVM devices, such adapter memory 1121. Thegenerator 1103 may maintain constant communication with the activatingsurgical instrument for the duration of the activation.

System 1101 also allows for a generic adapter presence element. Whenfirst plugged in or powered on, the adapter 1115 would present thisadapter resistance to the generator 1103. The generator 1103 may thenrelay commands to the adapter 1115 to switch between the differentpresence elements corresponding to the different surgical instruments9007, 9008 connected to it. Accordingly, the generator 1103 is able touse its existing presence resistance circuit. The NVM memory 1121 existson the adapter 1115 for additional identification of the adapter and toprovide a level of security. In addition, the adapter 1115 has a serialI/O device, i.e. serial PIO integrated circuit 1133. The serial PIOintegrated circuit 1133 provides a communication link between thegenerator 1103 and the adapter 1115.

It may be possible to communicate over the handpiece serial bus usingserial communications to handpiece NVMs and UART style communication tothe control circuit 1119. According to one aspect, if SLOW serialcommunication is used (i.e. not overdrive) and a high speed serialprotocol is used, system 1101 may need to ensure that the communicationsprotocol does not generate a signal that looked like a serial resetpulse. This would allow better generator 1103 to adapter 1115communications and faster switching times between surgical instruments9007, 9008.

The system 1101 uses generator communications protocol and analogcircuit and allows the generator to accomplish decision making. It is asimple and efficient solution that uses a small number of circuitdevices.

FIG. 12 illustrates a communications architecture of system 1201 of agenerator 1203, which is one form of the generator 100 (FIGS. 1-3), andsurgical instruments 9007, 9008 shown in FIG. 9. According to FIG. 12,the generator 1205 is configured for delivering multiple energymodalities to a plurality of surgical instruments. As discussed hereinthe various energy modalities include, without limitation, ultrasonic,bipolar or monopolar RF, reversible and/or irreversible electroporation,and/or microwave energy modalities. As shown in FIG. 12, the generator1203 comprises a combined energy modality power output 1205, ahandswitch serial interface 1211, an handpiece serial interface 1213,and a presence interface 1209. In one aspect, the handpiece serialinterface 1213 allows for communication with the handpiece lines of thesurgical instruments 9007, 9008 and also allows for control of theadapter 1215. The generator 1203 provides the combined energy modalitypower output 1205 to an adapter 1215. The adapter 1215 comprises energystorage circuit 1217, control circuit 1219, a serial PIO integratedcircuit 1233, handswitch (HSW) #1 circuit 1231, handswitch (HSW) #2circuit 1271, handpiece switching mechanism 1221, presence switchingmechanism 1239, switching mechanism 1235, instrument power monitoring1237, and unique presence 1241. As shown in FIG. 12, the handswitch #1circuit 1231 and the handswitch #2 circuit 1271 may comprise generationand ADC circuits. In one aspect, handswitch #1 circuit 1231 and/orhandswitch #2 circuit 1271 comprise generation circuit with the abilityto generate handswitch waveforms.

The control circuit 1219 is coupled to the handswitch serial interface1211 of the generator 1203 while the serial PIO integrated circuit 1233is coupled to the handpiece serial interface 1213 as is the handpieceswitching mechanism 1221. Further, the control circuit 1119 is coupledto the handswitch #1 circuit 1231 and the handswitch #2 circuit 1271.The control circuit 1119 may comprise a processor, FPGA, CPLD, PLD,microcontroller, and/or ASIC, for example. In the example shown in FIG.12, the control circuit 1219 modulates two devices into at least onedigital waveform, which enable the generator 1203 to perform the buttonmonitoring and decision making. The control circuit 1219 also may allowfor communication to two independent surgical instruments could receiveeither waveform. The serial PIO integrated circuit 1233 is furthercoupled to the handpiece switching mechanism 1221, the instrument powermonitoring 1237, and the presence switching mechanism 1239. Theinstrument power monitoring 1237 and the serial PIO integrated circuit1233 may communicate results and failures to the generator 1203.

The switching mechanism 1223 is configured to receive the combinedRF/Ultrasonic power output 1205 from the generator 1203 and it may beprovided to the energy storage device 1225 or the switching mechanism1235. The control circuit 1219 is also coupled to the storage control1227 and storage monitoring 1229 of the energy storage circuit 1217. Theswitching mechanism 1235 may provide the power output received from theswitching mechanism 1223 to surgical instrument 9007, and/or surgicalinstrument 9008. The instrument power monitoring 1237 is coupled to thechannels for the power output to the surgical instrument 9007 andsurgical instrument 9008. The instrument power monitoring 1237 also mayensure that the switching mechanism 1235 is outputting power to correctlocation.

The handswitch #1 circuit 1231 and the handswitch #2 block 1271 arecoupled to the handswitch serial interfaces 9013, 9014 of the surgicalinstruments 9007, 9008, respectively. The handpiece switching mechanism1221 is coupled to the handpiece serial interface 1213 of the generator1203 and to the handpiece serial interfaces 9015, 9016 of the surgicalinstruments 9007, 9008, respectively. Further, the presence switchingmechanism 1239 is coupled to the presence interface 1209 of thegenerator 1203 and to the Presence Interfaces 9017, 9018 of the surgicalinstruments 9007, 9008, respectively. Further, Presence Switchingmechanism is coupled to the unique presence 1241. In one aspect,different instrument presence elements may be switched on an on-demandbasis using serial I/O or an adapter micro protocol.

A first communications protocol will be used to communicate to thecontrol circuit 1219 on the adapter 1215. The generator 1205 also mayhave the ability to monitor surgical instruments 9007, 9008 at once. Theadapter 1215 may comprise a circuit to provide handswitch signalgeneration (e.g., in handswitch #1 circuit 1231 and handswitch #2circuit 1271) along with ADCs to interpret this data. The adapter 1215may modulate two surgical instrument signals into at least a firstwaveform and may have the ability to read in the first and secondwaveforms. In various aspects, the second waveforms may be interpretedand translated into the format of the first waveforms. Further, thefirst protocol has the ability to send 12 bits at 615 bits/sec.

The control circuit 1219 may take the handswitch data from surgicalinstruments 9007, 9008 and modulate it into a first protocol. There area few ways of doing this, but it may mean that surgical instruments9007, 9008 may comprise a first protocol functionality. The system 1201could communicate 4-6 buttons from the surgical instrument 9007 and 4-6buttons from the surgical instrument 9008 in the first protocol frame.Alternatively, the system 1201 could use some form of addressing toaccess the surgical instruments 9007, 9008. The control circuit 1219 mayhave the ability to address separate devices by having the generator1203 send the control circuit 1219 different addresses split into twodifferent address spaces, one for surgical instrument 9007 and one forsurgical instrument 9008.

The handpiece communications may involve some form of switch that couldeither be controlled via a serial I/O device or through the controlcircuit 1219 via a first protocol style communication interface from thegenerator 1203. In one aspect, energy storage monitoring 1229 andswitching between surgical instruments 9007, 9008 and charging statescould be handled in this manner as well. Certain first protocoladdresses could be assigned to the data from the energy storage circuit1225 and to the surgical instruments 9007, 9008 themselves. Presenceelements could also be switched in with this format. Further, in oneaspect, the control circuit 1219 may translate frames into a separateformat, which may mean that the control circuit 1219 might need to makesome decisions on whether button presses on surgical instruments 9007,9008 are valid or not. The system 1201 would, however, allow thegenerator 1203 to fully monitor the surgical instruments 9007, 9008 atthe same time time-slicing or handling a new communications protocol onthe handswitch serial interface 1211 of the generator 1203. The system1201 uses generator communications to simultaneously detect the activityof two surgical instruments, even during activation.

According to some aspects of the present disclosure, various inputsmaybe used to predict a user's intention in operating a surgicalinstrument, and RF and/or ultrasonic energy may be delivered accordingto the user's intention.

FIG. 13 shows a block diagram 1300 illustrating the selection ofoperations of a surgical instrument based on various inputs. Thesurgical instrument may comprise an RF energy output and an ultrasonicenergy output. The surgical instrument may further comprise a first jawand a second jaw configured for pivotal movement between a closedposition and an open position.

A first input 1310 indicating a user selection of one of a first optionand a second option may be received. For example, the first option may aseal only option, and the second option may be a seal and cut option.The user selection may be received as a button selection. For example,the button may be a switch or trigger located at a handle of thesurgical instrument. Signal from a trigger aperture sensor may be fedvia ASIC (application specific integration circuit) in the surgicalinstrument to a generator of RF and/or ultrasonic signals.

A second input 1320 indicating whether the first jaw and the second jaware in the closed position or in the open position 1320 may be received.For example, a jaw aperture sensor in the surgical instrument may beused to sense the open or closed position, and a corresponding signalmay be fed via ASIC in the surgical instrument to the generator of RFand/or ultrasonic signals.

A third input 1330 indicating electrical impedance at the RF energyoutput may be received. Low electrical impedance may indicate a shortcondition, which may be caused by a stapled tissue. Medium electricalimpedance may indicate that a tissue is present without staples. Highelectrical impedance may indicate an open circuit condition.

Based at least in part on the first input 1310, the second input 1320and the third input 1330, a mode of operation for treating a tissue maybe selected 1340 from a plurality of modes of operation, which maycomprise a first mode wherein the RF energy output applies RF energy tothe tissue, and a second mode wherein the ultrasonic energy outputapplies ultrasonic energy to the tissue. The plurality of modes ofoperation may further comprise a third mode wherein the RF energy outputapplies RF energy to the tissue and the ultrasonic energy output appliesultrasonic energy to the tissue; and a fourth mode wherein no RF energyor ultrasonic energy is applied to the tissue.

A level of energy applied by the RF energy output or ultrasonic energyoutput may also be selected 1350 based at least in part on the firstinput, the second input and the third input. For example, an EEPROM(Electrically Erasable Programmable Read-Only Memory) located at thesurgical instrument or a non-volatile memory located at the generatormay be accessed to load a wave-shape table and other RF and/orultrasonic parameters such as voltage, current, power, and algorithm inorder to performed the desired operation in the most optimal way.

According to some aspects of the present disclosure, the first input1310, the second input 1320 and the third input 1330 may be received ata generator for providing RF energy and ultrasonic energy to thesurgical instrument, and the selections are performed at the generator.

FIG. 14 shows a logic diagram 1400 illustrating specific operations of asurgical instrument selected based on various inputs. In particular, thelogic diagram 1400 may be executed by multifunction surgical instrument108 coupled to the generator 100 as shown in FIGS. 1 and 2 to complete avariety of user intentions 1490. As described herein, the system may becontained in the generator 100, the plug or adapter, and/or the surgicalinstrument 108 or device. The logic described by the logic diagram 1400can be executed by any of the processing circuits described inconnection with FIGS. 5-12 (e.g., processor, controller, digital signalprocessor, control circuit, and/or logic device collectively referred toas “system”).

Accordingly, with reference now to FIGS. 1, 2, and 14, the surgicalinstrument 108 includes a mode selection button to select one of a sealonly mode 1414 or a seal and cut mode 1418. When the user presses 1410the mode selection button on the surgical instrument 108, the systemdetermines whether the user intended to employ the seal only mode 1414or the seal and cut mode 1418. The user election of the seal only mode1414 will be described first.

Accordingly, upon selecting the seal only mode 1414, the systemdetermines 1416 whether the clamp arm 146 of the surgical instrument 108is in an open position or a closed position and then measures theimpedance between the clamp arm 146 and the ultrasonic blade 149. Whenthe clamp arm 146 is in a closed position 1422 the measured electricalimpedance 1424 between the electrode in the clamp arm 146 and theultrasonic blade 149 is low 1438 or indicates a short circuit, thesystem assumes that stapled tissue is present between the jaws 125 andapplies 1440 low ultrasonic energy to the tissue located between theclamp arm 146 and the ultrasonic blade 149. Accordingly, the surgicalinstrument 108 completes the user intention of sealing 1442 stapledtissue located between the clamp arm 146 and the ultrasonic blade 149.

Still with reference to the seal only mode 1414 sequence, when the clamparm 146 is in a closed position 1422 and the measured electricalimpedance 1424 is within a range that indicates 1444 the presence oftissue without staples between the clamp arm 146 and the ultrasonicblade 149, the system applies 1446 RF energy according to apredetermined seal only algorithm. Accordingly, the surgical instrument108 completes the user intention 1448 of sealing a vessel or tissuebundle located between the clamp arm 146 and the ultrasonic blade 149.

Still with reference to the seal only mode 1414, when the seal only mode1414 is selected and the clamp arm 146 is in an open 1426 position, andthe measured electrical impedance 1428 is high 1450 or indicates an opencircuit, the system determines that an error has occurred and provides1452 an error indication but does not deliver either RF or ultrasonicenergy. Accordingly, the surgical instrument 108 completes the userintention 1454 of no job identified.

Still with reference to the seal only mode 1414 sequence, when the clamparm 146 is in an open position 1426 and the electrical impedance 1428 ismedium 1456 or indicates the presence of tissue located between theclamp arm 146 and the ultrasonic blade 149, the system determines thatthe user intends to perform spot coagulation and applies 1458 highvoltage RF energy to the tissue. Accordingly, the surgical instrument108 completes the user intention 1460 of spot coagulating the tissue.The RF energy provided for spot coagulation also may have a high crestfactor as shown and described in connection with FIG. 21.

Having described the seal only mode 1414 sequence, the description nowturns to the seal and cut mode 1418 sequence. When the seal and cut mode1418 option is selected, the system determines 1420 whether the clamparm 146 is in an open position or a closed position. When the clamp arm146 is in a closed position 1430 and the measured electrical impedance1432 is low 1462 or indicates the presence of a short circuit, thesystem determines that stapled tissue is located between the clamp arm146 and the ultrasonic blade 149 and applies 1464 low ultrasonic energyto the stapled tissue. Accordingly, the surgical instrument 108completes the user intention 1466 of sealing and cutting stapled tissuelocated between the clamp arm 146 and the ultrasonic blade 149.

Still with reference to the seal and cut mode 1418, when the clamp arm146 is in a closed 1430 and the measured electrical impedance 1432 ismedium 1468 or indicates that tissue without staples is present betweenthe clamp arm 146 and the ultrasonic blade 149, the system firstlyapplies 1470 RF energy to seal the tissue and secondly applies 1470ultrasonic energy to cut the tissue. Accordingly, the surgicalinstrument 108 completes the user intention 1472 of sealing and cuttinga vessel or tissue bundle located between the clamp arm 146 and theultrasonic blade 149.

Still with reference to the seal and cut mode 1418, when the clamp arm146 is in an open position 1434 and the measured electrical impedance1436 is high 1474 or indicates an open circuit, the system applies 1476high ultrasonic energy to the tissue. Accordingly, the surgicalinstrument 108 completes the user intention 1478 of back cutting orcreating an otomy.

Still with reference to the seal and cut mode 1418, when the clamp arm146 is in an open position 1434 and the measured electrical impedance1436 is medium 1480 or indicates that tissue is present between theclamp arm 146 and the ultrasonic blade 149, the system determines thatthe user intends to perform spot coagulation and applies 1482 highvoltage RF to the to the tissue. Accordingly, the surgical instrument108 completes the user intention 1484 of spot coagulation. The RF energyprovided for spot coagulation may have a high crest factor as shown anddescribed in connection with FIG. 21.

Therefore, according to aspects of the present disclosure, varioustissue effects can be provided in an automatic fashion. Therefore, auser does not need to access a complicated set of buttons or otherinputs to perform the desired operation.

FIGS. 15 and 16 provide illustration of system configuration for anexample circuit topology shown and described with regard to FIGS. 13-14The system configuration comprises a plurality sections, where theplurality of sections include a generator (labeled GENERATOR), aproximal plug (labeled PLUG 1), a cable, a distal plug (labeled PLUG 2),a handle of a surgical instrument, and an application portion (labeledAPP) of a surgical instrument. According to various aspects, theproximal plug may be a component of the generator, it may be a componentof cable, or it may be separate component. Similarly, the distal plugmay be a component of the cable, it may be a component of handle, or itmay be separate component.

FIG. 15 provides an illustration of a system 6600 configuration for anexample circuit topology shown and described with regard to FIGS. 13-14,including MOSFET switches and a control circuit in the handle,configured to manage RF and ultrasonic currents output by a generatoraccording to one aspect of the present disclosure. The system 6600includes electro-mechanical or solid state switches such as MOSFETswitches and a control circuit in the handle. The generator comprisesinterfaces for an ultrasonic signal 6601, an interface for an RF signal6603, a primary return terminal interface 6605, an HSW interface 6607, asecondary return terminal interface 6609, an identification interface6611, and a presence interface 6613. The proximal plug comprisesmatching interfaces to those of generator, an EEPROM 6617, and presenceresistor 6619. The proximal plug outputs are carried through the cableand the distal plug to the handle without any component circuitry ineither the cable or the distal plug. The handle comprises the MOSFETswitches 6615 that are each coupled to rectifier circuits 6621, whichare each coupled to a pair of coupling inductors 6623, also in thehandle. The rectifier circuits 6621 each comprise at least one diode andat least one capacitor. The control circuit 6627 (e.g., ASIC) is coupledto a driver circuit 6625 that feeds the coupling inductors 6623 and therectifier circuits 6621 to control the state of the MOSFET switches6615. The driver circuit 6625 and control circuit 6627 are located inthe handle. The handle further comprises resonator 6629, diode andcapacitor circuits 6631, EEPROM 6635, and switch array 6637. The switcharray 6637 may comprise electro-mechanical devices, transistor devices,and the like. The transistor devices may include bipolar junctiontransistors (BJT), FETs, MOSFETs, or a combination thereof. Therectifier portion of the diode and capacitor circuit 6631 is coupled tothe HSW interface 6607 and the secondary return terminal interface 6609of the generator and feed into control circuit 6627.

The application portion comprises EEPROM 6639, presence resistor 6641,and outputs for RF and ultrasonic energy 6643, 6645, respectively.EEPROM 6639 and presence resistor 6241 are coupled to control circuit6627. The system 6600 allows switching between an RF mode and anultrasonic mode and allows for a low cost cable configuration.

FIG. 16 provides an illustration of a system 6900 configuration for anexample circuit topology shown and described with regard to FIGS. 13-14,including bandstop filters and a control circuit in the handle,configured to manage RF and ultrasonic currents output by a generatoraccording to one aspect of the present disclosure. The system 6900includes bandstop filters and a control circuit in the handle. Thegenerator comprises interfaces for an ultrasonic signal 6901, aninterface for an RF signal 6903, a primary return terminal interface6905, an HSW interface 6907, a secondary return terminal interface 6909,an identification interface 6911, and a presence interface 6913. Theproximal plug comprises matching interfaces to those of generator, anEEPROM 6917, and presence resistor 6919. The proximal plug outputs arecarried through the cable and distal plug without any componentcircuitry in either the cable or the distal plug. The handle comprises apair of bandstop filters 6915, rectifier circuit 6931, EEPROM 6935,control circuit 6927, switch array 6937, and resonator 6929. Rectifiercircuit 6931 comprises at least one diode and at least one capacitor.Control circuit 6927 is coupled to EEPROM 6935, switch array 6937, andrectifier circuit 6931. The switch array 6937 may compriseelectro-mechanical devices, transistor devices, and the like. Thetransistor devices may include bipolar junction transistors (BJT), FETs,MOSFETs, or a combination thereof.

The application portion comprises EEPROM 6939, presence resistor 6941,and outputs for RF and ultrasonic energy 6943, 6945, respectively. Thepair of bandstop filters 6915 are coupled to the outputs for RF andultrasonic energy 6943, 6945. EEPROM 6939 and presence resistor 6941 arecoupled to control circuit 6927. The system 6900 allows switchingbetween an RF mode and an ultrasonic mode and supports mixed outputfrequencies, which allows tissues impedance sensing while the ultrasonicoutput is active. It also provides for a low cost cable configuration.

Examples of waveforms representing energy for delivery from a generatorare illustrated in FIGS. 17-21. FIG. 17 illustrates an example graph 600showing first and second individual waveforms representing an RF outputsignal 602 and an ultrasonic output signal 604 superimposed on the sametime and voltage scale for comparison purposes. These output signals602, 604 are provided at the ENERGY output of the generator 100. Time(t) is shown along the horizontal axis and voltage (V) is shown alongthe vertical axis. The RF output signal 602 has a frequency of about 330kHz RF and a peak-to-peak voltage of ±1V. The ultrasonic output signal604 has a frequency of about 55 kHz and a peak-to-peak voltage of ±1V.It will be appreciated that the time (t) scale along the horizontal axisand the voltage (V) scale along the vertical axis are normalized forcomparison purposes and may be different actual implementations, orrepresent other electrical parameters such as current.

FIG. 18 illustrates an example graph 610 showing the sum of the twooutput signals 602, 604 shown in FIG. 17. Time (t) is shown along thehorizontal axis and voltage (V) is shown along the vertical axis. Thesum of the RF output signal 602 and the ultrasonic output signal 604shown in FIG. 17 produces a combined output signal 612 having a 2Vpeak-to-peak voltage, which is twice the amplitude of the original RFand ultrasonic signals shown (1V peak-to-peak) shown in FIG. 17. Anamplitude of twice the original amplitude can cause problems with theoutput section of the generator, such as distortion, saturation,clipping of the output, or stresses on the output components. Thus, themanagement of a single combined output signal 612 that has multipletreatment components is an important aspect of the generator 500 shownin FIG. 8. There are a variety of ways to achieve this management. Inone form, one of the two RF or ultrasonic output signals 602, 604 can bedependent on the peaks of the other output signal. In one aspect, the RFoutput signal 602 may depend on the peaks of the ultrasonic signal 604,such that the output is reduced when a peak is anticipated. Such afunction and resulting waveform is shown in FIG. 19.

For example, FIG. 19 illustrates an example graph 620 showing a combinedoutput signal 622 representative of a dependent sum of the outputsignals 602, 604 shown in FIG. 17. Time (t) is shown along thehorizontal axis and voltage (V) is shown along the vertical axis. Asshown in FIG. 17, the RF output signal 602 component of FIG. 17 dependson the peaks of the ultrasonic output signal 604 component of FIG. 17such that the amplitude of the RF output signal component of thedependent sum combined output signal 622 is reduced when an ultrasonicpeak is anticipated. As shown in the example graph 620 in FIG. 17, thepeaks have been reduced from 2 to 1.5. In another form, one of theoutput signals is a function of the other output signal.

For example, FIG. 20 illustrates an example graph of an analog waveform630 showing an output signal 632 representative of a dependent sum ofthe output signals 602, 604 shown in FIG. 17. Time (t) is shown alongthe horizontal axis and voltage (V) is shown along the vertical axis. Asshown in FIG. 20, the RF output signal 602 is a function of theultrasonic output signal 604. This provides a hard limit on theamplitude of the output. As shown in FIG. 20, the ultrasonic outputsignal 604 is extractable as a sine wave while the RF output signal 602has distortion but not in a way to affect the coagulation performance ofthe RF output signal 602.

A variety of other techniques can be used for compressing and/orlimiting the waveforms of the output signals. It should be noted thatthe integrity of the ultrasonic output signal 604 (FIG. 17) can be moreimportant than the integrity of the RF output signal 602 (FIG. 17) aslong as the RF output signal 602 has low frequency components for safepatient levels so as to avoid neuro-muscular stimulation. In anotherform, the frequency of an RF waveform can be changed on a continuousbasis in order to manage the peaks of the waveform. Waveform control isimportant as more complex RF waveforms, such as a coagulation-typewaveform 642, as illustrated in the graph 640 shown in FIG. 21, areimplemented with the system. Again, time (t) is shown along thehorizontal axis and voltage (V) is shown along the vertical axis. Thecoagulation-type waveform 642 illustrated in FIG. 21 has a crest factorof 5.8, for example.

While various details have been set forth in the foregoing description,it will be appreciated that the various aspects of the serialcommunication protocol for medical device may be practiced without thesespecific details. For example, for conciseness and clarity selectedaspects have been shown in block diagram form rather than in detail.Some portions of the detailed descriptions provided herein may bepresented in terms of instructions that operate on data that is storedin a computer memory. Such descriptions and representations are used bythose skilled in the art to describe and convey the substance of theirwork to others skilled in the art. In general, an algorithm refers to aself-consistent sequence of steps leading to a desired result, where a“step” refers to a manipulation of physical quantities which may, thoughneed not necessarily, take the form of electrical or magnetic signalscapable of being stored, transferred, combined, compared, and otherwisemanipulated. It is common usage to refer to these signals as bits,values, elements, symbols, characters, terms, numbers, or the like.These and similar terms may be associated with the appropriate physicalquantities and are merely convenient labels applied to these quantities.

Unless specifically stated otherwise as apparent from the foregoingdiscussion, it is appreciated that, throughout the foregoingdescription, discussions using terms such as “processing” or “computing”or “calculating” or “determining” or “displaying” or the like, refer tothe action and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

It is worthy to note that any reference to “one aspect,” “an aspect,”“one form,” or “an form” means that a particular feature, structure, orcharacteristic described in connection with the aspect is included in atleast one aspect. Thus, appearances of the phrases “in one aspect,” “inan aspect,” “in one form,” or “in an form” in various places throughoutthe specification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Some aspects may be described using the expression “coupled” and“connected” along with their derivatives. It should be understood thatthese terms are not intended as synonyms for each other. For example,some aspects may be described using the term “connected” to indicatethat two or more elements are in direct physical or electrical contactwith each other. In another example, some aspects may be described usingthe term “coupled” to indicate that two or more elements are in directphysical or electrical contact. The term “coupled,” however, also maymean that two or more elements are not in direct contact with eachother, but yet still co-operate or interact with each other.

It is worthy to note that any reference to “one aspect,” “an aspect,”“one form,” or “an form” means that a particular feature, structure, orcharacteristic described in connection with the aspect is included in atleast one aspect. Thus, appearances of the phrases “in one aspect,” “inan aspect,” “in one form,” or “in an form” in various places throughoutthe specification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Although various forms have been described herein, many modifications,variations, substitutions, changes, and equivalents to those forms maybe implemented and will occur to those skilled in the art. Also, wherematerials are disclosed for certain components, other materials may beused. It is therefore to be understood that the foregoing descriptionand the appended claims are intended to cover all such modifications andvariations as falling within the scope of the disclosed forms. Thefollowing claims are intended to cover all such modification andvariations.

In a general sense, those skilled in the art will recognize that thevarious aspects described herein which can be implemented, individuallyand/or collectively, by a wide range of hardware, software, firmware, orany combination thereof can be viewed as being composed of various typesof “electrical circuitry.” Consequently, as used herein “electricalcircuitry” includes, but is not limited to, electrical circuitry havingat least one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of randomaccess memory), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, or optical-electricalequipment). Those having skill in the art will recognize that thesubject matter described herein may be implemented in an analog ordigital fashion or some combination thereof.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, or examples can be implemented,individually and/or collectively, by a wide range of hardware, software,firmware, or virtually any combination thereof. In one form, severalportions of the subject matter described herein may be implemented viaApplication Specific Integrated Circuits (ASICs), Field ProgrammableGate Arrays (FPGAs), digital signal processors (DSPs), or otherintegrated formats. However, those skilled in the art will recognizethat some aspects of the forms disclosed herein, in whole or in part,can be equivalently implemented in integrated circuits, as one or morecomputer programs running on one or more computers (e.g., as one or moreprograms running on one or more computer systems), as one or moreprograms running on one or more processors (e.g., as one or moreprograms running on one or more microprocessors), as firmware, or asvirtually any combination thereof, and that designing the circuitryand/or writing the code for the software and or firmware would be wellwithin the skill of one of skill in the art in light of this disclosure.In addition, those skilled in the art will appreciate that themechanisms of the subject matter described herein are capable of beingdistributed as a program product in a variety of forms, and that anillustrative form of the subject matter described herein appliesregardless of the particular type of signal bearing medium used toactually carry out the distribution. Examples of a signal bearing mediuminclude, but are not limited to, the following: a recordable type mediumsuch as a floppy disk, a hard disk drive, a Compact Disc (CD), a DigitalVideo Disk (DVD), a digital tape, a computer memory, etc.; and atransmission type medium such as a digital and/or an analogcommunication medium (e.g., a fiber optic cable, a waveguide, a wiredcommunications link, a wireless communication link (e.g., transmitter,receiver, transmission logic, reception logic, etc.), etc.).

All of the above-mentioned U.S. patents, U.S. patent applicationpublications, U.S. patent applications, foreign patents, foreign patentapplications, non-patent publications referred to in this specificationand/or listed in any Application Data Sheet, or any other disclosurematerial are incorporated herein by reference, to the extent notinconsistent herewith. As such, and to the extent necessary, thedisclosure as explicitly set forth herein supersedes any conflictingmaterial incorporated herein by reference. Any material, or portionthereof, that is said to be incorporated by reference herein, but whichconflicts with existing definitions, statements, or other disclosurematerial set forth herein will only be incorporated to the extent thatno conflict arises between that incorporated material and the existingdisclosure material.

One skilled in the art will recognize that the herein describedcomponents (e.g., operations), devices, objects, and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are contemplated.Consequently, as used herein, the specific exemplars set forth and theaccompanying discussion are intended to be representative of their moregeneral classes. In general, use of any specific exemplar is intended tobe representative of its class, and the non-inclusion of specificcomponents (e.g., operations), devices, and objects should not be takenlimiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely example, and that in fact many other architectures may beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

In some instances, one or more components may be referred to herein as“configured to,” “configurable to,” “operable/operative to,”“adapted/adaptable,” “able to,” “conformable/conformed to,” etc. Thoseskilled in the art will recognize that “configured to” can generallyencompass active-state components and/or inactive-state componentsand/or standby-state components, unless context requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of the subject matter described herein.It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

In certain cases, use of a system or method may occur in a territoryeven if components are located outside the territory. For example, in adistributed computing context, use of a distributed computing system mayoccur in a territory even though parts of the system may be locatedoutside of the territory (e.g., relay, server, processor, signal-bearingmedium, transmitting computer, receiving computer, etc. located outsidethe territory).

A sale of a system or method may likewise occur in a territory even ifcomponents of the system or method are located and/or used outside theterritory. Further, implementation of at least part of a system forperforming a method in one territory does not preclude use of the systemin another territory.

Although various forms have been described herein, many modifications,variations, substitutions, changes, and equivalents to those forms maybe implemented and will occur to those skilled in the art. Also, wherematerials are disclosed for certain components, other materials may beused. It is therefore to be understood that the foregoing descriptionand the appended claims are intended to cover all such modifications andvariations as falling within the scope of the disclosed forms. Thefollowing claims are intended to cover all such modification andvariations.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

While several forms have been illustrated and described, it is not theintention of the applicant to restrict or limit the scope of theappended claims to such detail. Numerous variations, changes, andsubstitutions will occur to those skilled in the art without departingfrom the scope of the invention. Moreover, the structure of each elementassociated with the described forms can be alternatively described as ameans for providing the function performed by the element. Accordingly,it is intended that the described forms be limited only by the scope ofthe appended claims.

Reference throughout the specification to “various forms,” “some forms,”“one form,” or “an form” means that a particular feature, structure, orcharacteristic described in connection with the form is included in atleast one form. Thus, appearances of the phrases “in various forms,” “insome forms,” “in one form,” or “in an form” in places throughout thespecification are not necessarily all referring to the same form.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more forms. Thus, theparticular features, structures, or characteristics illustrated ordescribed in connection with one form may be combined, in whole or inpart, with the features structures, or characteristics of one or moreother forms without limitation.

Various aspects of the subject matter described herein are set out inthe following numbered clauses:

1. A system for managing RF and ultrasonic signals output by agenerator, comprising: a surgical instrument comprising an RF energyoutput, an ultrasonic energy output, and a circuit configured to receivea combined Radio Frequency (RF) and ultrasonic signal from thegenerator; wherein the circuit is configured to filter frequency contentof the combined signal and is configured to provide a first filteredsignal to the RF energy output and a second filtered signal to theultrasonic energy output.

2. The system of clause 1, wherein the circuit comprises a resonator.

3. The system of clause 1 or 2, wherein the circuit comprises a highfrequency band-stop filter.

4. The system of any one of clauses 1-3, wherein the high frequencyband-stop filter comprises a first LC filter circuit and a second LCfilter circuit.

5. The system of any one of clauses 1-4, wherein the combined signalcomprises a 350 kHz component.

6. The system of any one of clauses 1-5, wherein the combined signalcomprises a 55 kHz component.

7. The system of any of clauses 1-6, wherein the surgical instrument isconfigured to apply a therapy from the RF energy output and theultrasonic energy output simultaneously.

8. A system for managing RF and ultrasonic signals output by agenerator, comprising: a surgical instrument comprising an RF energyoutput, an ultrasonic energy output, and a circuit configured to receivea combined Radio Frequency (RF) and ultrasonic signal from thegenerator; wherein the circuit is configured to switch between the RFenergy output and the ultrasonic energy output according to the combinedsignal received from the generator.

9. The system of clause 8, wherein the circuit comprises two pairs ofMOSFET switches.

10. The system of clause 9, wherein each of the two pairs of MOSFETswitches is connected source to source.

11. The system of clause 9 or 10, further comprising a first coupledinductor and a second coupled inductor.

12. The system of clause 11, wherein the gate of each MOSFET of a firstpair of MOSFET switches is coupled together and is coupled to the firstcoupled inductor.

13. The system of clause 11 or 12, wherein the gate of each MOSFET of asecond pair of MOSFET switches is coupled together and is coupled to thesecond coupled inductor.

14. The system of any of clauses 11-13, further comprising a firstcapacitor and a second capacitor, wherein the first capacitor is coupledto the primary side of the first coupled inductor and the secondcapacitor is coupled to the primary side of the second coupled inductor.

15. The system of any one of clauses 9-14, further comprising an ASIC, afirst pulse transformer, and a second pulse transformer, wherein theASIC is coupled to the first and second pulse transformers, and whereinthe first pulse transformer is coupled to a first pair of the two pairsof MOSFET switches and the second pulse transformer is coupled to asecond pair of the two pairs of MOSFET switches.

16. The system of clause 15, wherein each of the two pairs of MOSFETswitches are connected source to source.

17. The system of clause 16, wherein the gate of each MOSFET of thefirst pair of MOSFET switches is coupled together and is coupled to thefirst pulse transformer.

18. The system of clause 16 or 17, wherein the gate of each MOSFET of asecond pair of MOSFET switches is coupled together and is coupled to thesecond pulse transformer.

19. The system of clause 18, wherein the circuit comprises a firstswitching element coupled to the RF energy output and a second switchingelement coupled to the ultrasonic energy output.

20. The system of clause 19, wherein the first switching element and thesecond switching element are each electromechanical relays.

21. The system of clause 19 or 20, wherein the first switching elementand the second switching element are coupled to an ASIC.

22. The system of any one of clauses 19-21, further comprising a switchmechanism to actuate the first switching element and the secondswitching element.

23. The system of clause 22, wherein the switch mechanism is amechanical rocker style switch mechanism.

24. A system for managing RF and ultrasonic signals output by agenerator, comprising: a surgical instrument comprising an RF energyoutput, an ultrasonic energy output, and a circuit configured to receivea combined Radio Frequency (RF) and ultrasonic signal from thegenerator; wherein the circuit comprises: a filter circuit configured tofilter frequency content of the combined signal; and a switching elementconfigured to switch between an on-state and an off-state to one of theRF energy output or the ultrasonic energy output according to thecombined signal received from the generator.

25. The system of clause 24, wherein the filter circuit is coupled tothe ultrasonic energy output and the switching element is coupled to theRF energy output.

26. A method for operating a surgical instrument, the surgicalinstrument comprising a radio frequency (RF) energy output, anultrasonic energy output, and a first jaw and a second jaw configuredfor pivotal movement between a closed position and an open position, themethod comprising: receiving a first input indicating a user selectionof one of a first option and a second option; receiving a second inputindicating whether the first jaw and the second jaw are in the closedposition or in the open position; receiving a third input indicatingelectrical impedance at the RF energy output; and selecting a mode ofoperation for treating a tissue from a plurality of modes of operationbased at least in part on the first input, the second input and thethird input, wherein the plurality of modes of operation comprises: afirst mode wherein the RF energy output applies RF energy to the tissue;and a second mode wherein the ultrasonic energy output appliesultrasonic energy to the tissue.

27. The method of clause 26, wherein the first option is a seal onlyoption, and the second option is a seal and cut option.

28. The method of clause 26, wherein the user selection is a buttonselection.

29. The method of clause 26, wherein the plurality of modes of operationfurther comprises: a third mode wherein the RF energy output applies RFenergy to the tissue and the ultrasonic energy output applies ultrasonicenergy to the tissue; and a fourth mode wherein no RF energy orultrasonic energy is applied to the tissue.

30. The method of clause 29, wherein the third mode is selected when thefirst input indicates the second option, the second input indicates theclosed position, and the third input indicates medium electricalimpedance, wherein RF energy is applied before ultrasonic energy isapplied.

31. The method of clause 29, wherein the fourth mode is selected whenthe first input indicates the first option, the second input indicatesthe open position, and the third input indicates high electricalimpedance.

32. The method of clause 26, further comprising selecting a level ofenergy applied by the RF energy output based at least in part on thefirst input, the second input and the third input.

33. The method of clause 32, wherein the first mode is selected and thelevel of energy applied by the RF energy output is selected as high,when the second input indicates the open position, and the third inputindicates medium electrical impedance.

34. The method of clause 26, further comprising selecting a level ofenergy applied by the ultrasonic energy output based at least in part onthe first input, the second input and the third input.

35. The method of clause 34, wherein the second mode is selected and thelevel of energy applied by the ultrasonic energy output is selected aslow, when the second input indicates the closed position, and the thirdinput indicates low electrical impedance.

36. The method of clause 34, wherein the second mode is selected and thelevel of energy applied by the ultrasonic energy output is selected ashigh, when the first input indicates the second option, the second inputindicates the open position, and the third input indicates highelectrical impedance.

37. The method of clause 26, wherein the first mode is selected when thefirst input indicates the first option, the second input indicates theclosed position, and the third input indicates medium electricalimpedance.

38. The method of clause 26, further comprising selecting a waveform ofenergy applied by the RF energy output or the ultrasonic energy outputbased at least in part on the first input, the second input and thethird input.

39. A generator for delivering radio frequency (RF) energy andultrasonic energy to a surgical instrument, the surgical instrumentcomprising a first jaw and a second jaw configured for pivotal movementbetween a closed position and an open position, the generator beingconfigured to: receive a first input indicating a user selection of oneof a first option and a second option; receive a second input indicatingwhether the first jaw and the second jaw are in the closed position orin the open position; receive a third input indicating electricalimpedance at a RF energy output of the surgical instrument; and select amode of operation for treating a tissue from a plurality of modes ofoperation based at least in part on the first input, the second inputand the third input, wherein the plurality of modes of operationcomprises: a first mode wherein the generator delivers RF energy to thesurgical instrument; and a second mode wherein the generator deliversultrasonic energy to the surgical instrument.

40. The generator of clause 39, wherein the plurality of modes ofoperation further comprises: a third mode wherein the generator deliversRF energy and ultrasonic energy to the surgical instrument; and a fourthmode wherein the generator delivers no RF energy or ultrasonic energy tothe surgical instrument.

41. The generator of clause 39, wherein the generator is furtherconfigured to deliver RF energy to the surgical instrument at a leveldetermined based at least in part on the first input, the second inputand the third input.

42. The generator of clause 41, wherein the generator is configured toselect the first mode and the level of RF energy is determined as high,when the second input indicates the open position, and the third inputindicates medium electrical impedance.

43. The generator of clause 39, wherein the generator is furtherconfigured to deliver ultrasonic energy to the surgical instrument at alevel determined based at least in part on the first input, the secondinput and the third input.

44. The generator of clause 43, wherein the generator is configured toselect the second mode and the level of ultrasonic energy is determinedas low, when the second input indicates the closed position, and thethird input indicates low electrical impedance.

45. A surgical instrument comprising: a first jaw and a second jawconfigured for pivotal movement between a closed position and an openposition; a radio frequency (RF) energy output configured to apply RFenergy to a tissue at least when a first mode of operation is selected;and an ultrasonic energy output configured to apply ultrasonic energy tothe tissue at least when a second mode of operation is selected, whereina mode of operation is selected from a plurality of modes of operationcomprising the first mode and the second mode based at least in part ona first input, a second input and a third input, wherein: the firstinput indicates a user selection of one of a first option and a secondoption; the second input indicates whether the first jaw and the secondjaw are in the closed position or in the open position; and the thirdinput indicates electrical impedance at the RF energy output.

The invention claimed is:
 1. A method of a generator for operating asurgical instrument, the surgical instrument comprising a radiofrequency (RF) energy output, an ultrasonic energy output, and a firstjaw and a second jaw configured for pivotal movement between a closedposition and an open position, the method comprising: receiving a firstinput indicating a user selection of one of a first option and a secondoption; receiving a second input indicating whether the first jaw andthe second jaw are in the closed position or in the open position;receiving a third input indicating electrical impedance at the RF energyoutput; and selecting, by the generator without additional user inputother than from the first input, a mode of operation for treating atissue from a plurality of at least eight modes of operation based atleast in part on the first input, the second input and the third input,wherein the mode of operation is different than the first option and thesecond option, and wherein the plurality of at least eight modes ofoperation comprises: a first mode of performing a spot coagulateoperation wherein the RF energy output applies RF energy to the tissue;a second mode of performing a back cut or creating an otomy wherein theultrasonic energy output applies a first level of ultrasonic energy tothe tissue sufficient to perform the back cut or create the otomy; and athird mode of assuming the tissue is stapled tissue and applying asecond level of ultrasonic energy by the ultrasonic energy outputsufficient to seal the stapled tissue.
 2. The method of claim 1, whereinthe first option is a seal only option, and the second option is a sealand cut option.
 3. The method of claim 1, wherein the user selection isa button selection.
 4. The method of claim 1, wherein the plurality ofat least eight modes of operation further comprises: a fourth mode ofapplying an RF seal only algorithm to seal the tissue.
 5. The method ofclaim 1, wherein the plurality of at least eight modes of operationfurther comprises a fifth mode of providing an error and delivering noenergy to indicate that no valid function has been identified.
 6. Themethod of claim 5, wherein the fifth mode is selected when the firstinput indicates the first option, the second input indicates the openposition, and the third input indicates a measure of the electricalimpedance indicative of an open circuit condition.
 7. The method ofclaim 1, further comprising selecting a level of the RF energy appliedby the RF energy output based at least in part on the first input, thesecond input and the third input.
 8. The method of claim 7, wherein thefirst mode is selected and the level of the RF energy applied by the RFenergy output is selected as higher than 200 kHz, when the second inputindicates the open position, and the third input indicates a measure ofthe electrical impedance indicative of a condition of the tissue beingpresent at the first and second jaws without staples.
 9. The method ofclaim 1, further comprising selecting the first or the second level ofthe ultrasonic energy applied by the ultrasonic energy output based atleast in part on the first input, the second input and the third input.10. The method of claim 9, wherein the second mode is selected and thefirst or the second level of ultrasonic energy applied by the ultrasonicenergy output is selected as the first level of ultrasonic energy, whenthe second input indicates the closed position, and the third inputindicates a measure of the electrical impedance indicative of a shortcircuit condition.
 11. The method of claim 9, wherein the second mode isselected and the first or the second level of ultrasonic energy appliedby the ultrasonic energy output is selected as higher than 200 kHz, whenthe first input indicates the second option, the second input indicatesthe open position, and the third input indicates a measure of theelectrical impedance indicative of an open circuit condition.
 12. Themethod of claim 1, wherein the first mode is selected when the firstinput indicates the first option, the second input indicates the closedposition, and the third input indicates a measure of the electricalimpedance indicative of a condition of the tissue being present at thefirst and second jaws without staples.
 13. The method of claim 1,further comprising selecting a waveform of the RF energy applied by theRF energy output or the ultrasonic energy applied by the ultrasonicenergy output based at least in part on the first input, the secondinput and the third input.
 14. A generator for delivering radiofrequency (RF) energy and ultrasonic energy to a surgical instrument,the surgical instrument comprising a first jaw and a second jawconfigured for pivotal movement between a closed position and an openposition, the generator being configured to: receive a first inputindicating a user selection of one of a first option and a secondoption; receive a second input indicating whether the first jaw and thesecond jaw are in the closed position or in the open position; receive athird input indicating electrical impedance at a RF energy output of thesurgical instrument; and select, without additional user input otherthan from the first input, a mode of operation for treating a tissuefrom a plurality of at least eight modes of operation based at least inpart on the first input, the second input and the third input, whereinthe mode of operation is different than the first option and the secondoption, and wherein the plurality of at least eight modes of operationcomprises: a first mode wherein the generator delivers RF energy to thesurgical instrument; a second mode wherein the generator delivers afirst level of ultrasonic energy to an ultrasonic energy output of thesurgical instrument; and a third mode of assuming the tissue is stapledtissue and applying a second level of ultrasonic energy by theultrasonic energy output sufficient to seal the stapled tissue.
 15. Thegenerator of claim 14, wherein the plurality of at least eight modes ofoperation further comprises: a fourth mode of applying an RF seal onlyalgorithm to seal the tissue.
 16. The generator of claim 14, wherein thegenerator is further configured to deliver RF energy to the surgicalinstrument at a level determined based at least in part on the firstinput, the second input and the third input.
 17. The generator of claim16, wherein the generator is configured to select the first mode and thelevel of the RF energy is determined as higher than 200 kHz, when thesecond input indicates the open position, and the third input indicatesa measure of the electrical impedance indicative of a condition of thetissue being present at the first and second jaws without staples. 18.The generator of claim 14, wherein the generator is further configuredto deliver the ultrasonic energy to the surgical instrument at the firstor the second level determined based at least in part on the firstinput, the second input and the third input.
 19. The generator of claim18, wherein the generator is configured to select the second mode andthe level of ultrasonic energy is determined as the first level ofultrasonic energy, when the second input indicates the closed position,and the third input indicates a measure of the electrical impedanceindicative of a short circuit condition.
 20. A surgical instrumentcomprising: a first jaw and a second jaw configured for pivotal movementbetween a closed position and an open position; a radio frequency (RF)energy output configured to apply RF energy to a tissue at least when afirst mode of operation of performing a spot coagulate operation isselected; and an ultrasonic energy output configured to: apply a firstlevel of ultrasonic energy to the tissue sufficient to perform a backcut or create an otomy at least when a second mode of operation isselected; and apply a second level of ultrasonic energy sufficient toseal the tissue when a third mode of operation of assuming the tissue isstapled tissue is selected, wherein: the surgical instrument isconfigured to operate in at least eight modes of operation, wherein amode of operation among the at least eight modes of operation isselected, by a generator, the at least eight modes of operationcomprising the first mode of operation, the second mode of operation,and the third mode of operation, and the selection is based at least inpart on a first input, a second input and a third input, wherein: thefirst input indicates a user selection of one of a first option and asecond option; the second input indicates whether the first jaw and thesecond jaw are in the closed position or in the open position; the thirdinput indicates electrical impedance at the RF energy output; and themode of operation is different than the first option and the secondoption.